TY - JOUR AU - Amidei, Jacopo AU - Nieto, Rubén AU - Kaltenbrunner, Andreas AU - Ferreira De Sá, Gregorio Jose AU - Serrat, Mayte AU - Albajes, Klara PY - 2025/3/31 TI - Exploring the Capacity of Large Language Models to Assess the Chronic Pain Experience: Algorithm Development and Validation JO - J Med Internet Res SP - e65903 VL - 27 KW - large language models KW - fibromyalgia KW - chronic pain KW - written narratives KW - pain narratives KW - automated assessment KW - pain severity KW - pain disability N2 - Background: Chronic pain, affecting more than 20% of the global population, has an enormous pernicious impact on individuals as well as economic ramifications at both the health and social levels. Accordingly, tools that enhance pain assessment can considerably impact people suffering from pain and society at large. In this context, assessment methods based on individuals? personal experiences, such as written narratives (WNs), offer relevant insights into understanding pain from a personal perspective. This approach can uncover subjective, intricate, and multifaceted aspects that standardized questionnaires can overlook. However, WNs can be time-consuming for clinicians. Therefore, a tool that uses WNs while reducing the time required for their evaluation could have a significantly beneficial impact on people's pain assessment. Objective: This study is the first evaluation of the potential of applying large language models (LLMs) to assist clinicians in assessing patients? pain expressed through WNs. Methods: We performed an experiment based on 43 WNs made by people with fibromyalgia and qualitatively evaluated in a prior study. Focusing on pain severity and disability, we prompt GPT-4 (with temperature parameter settings 0 or 1) to assign scores and scores? explanations, to these WNs. Then, we quantitatively compare GPT-4 scores with experts? scores of the same narratives, using statistical measures such as Pearson correlations, root mean squared error, the weighted version of the Gwet agreement coefficient, and Krippendorff ?. Additionally, 2 experts specialized in chronic pain conducted a qualitative analysis of the scores? explanation to assess their accuracy and potential applicability of GPT?s analysis for future pain narrative evaluations. Results: Our analysis reveals that GPT-4?s performance in assessing pain narratives yielded promising results. GPT-4 was comparable in terms of agreement with experts (with a weighted percentage agreement higher than 0.95), correlations with standardized measurements (for example in the range of 0.43 and 0.49 between the Revised Fibromyalgia Impact Questionnaire and GTP-4 with temperatures 1), and low error rates (root mean squared error of 1.20 for severity and 1.44 for disability). Moreover, experts generally deemed the ratings provided by GPT-4, as well as the scores? explanation, to be adequate. However, we observe that GPT has a slight tendency to overestimate pain severity and disability with a lower SD than expert estimates. Conclusions: These findings underline the potential of LLMs in facilitating the assessment of WNs of people with fibromyalgia, offering a novel approach to understanding and evaluating patient pain experiences. Integrating automated assessments through LLMs presents opportunities for streamlining and enhancing the assessment process, paving the way for improved patient care and tailored interventions in the chronic pain management field. UR - https://www.jmir.org/2025/1/e65903 UR - http://dx.doi.org/10.2196/65903 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/65903 ER - TY - JOUR AU - Skoric, James AU - Lomanowska, M. Anna AU - Janmohamed, Tahir AU - Lumsden-Ruegg, Heather AU - Katz, Joel AU - Clarke, Hance AU - Rahman, Abidur Quazi PY - 2025/3/28 TI - Predicting Clinical Outcomes at the Toronto General Hospital Transitional Pain Service via the Manage My Pain App: Machine Learning Approach JO - JMIR Med Inform SP - e67178 VL - 13 KW - chronic pain KW - transitional pain KW - pain interference KW - machine learning KW - prediction model KW - manage my pain KW - pain app KW - clinical outcome KW - Toronto KW - Canada KW - transitional pain service KW - pain service KW - pain KW - app KW - application KW - prognosis KW - chronic pain management KW - digital health KW - digital health tool KW - pain management KW - machine learning methods KW - prediction KW - machine learning models KW - logistic regression N2 - Background: Chronic pain is a complex condition that affects more than a quarter of people worldwide. The development and progression of chronic pain are unique to each individual due to the contribution of interacting biological, psychological, and social factors. The subjective nature of the experience of chronic pain can make its clinical assessment and prognosis challenging. Personalized digital health apps, such as Manage My Pain (MMP), are popular pain self-tracking tools that can also be leveraged by clinicians to support patients. Recent advances in machine learning technologies open an opportunity to use data collected in pain apps to make predictions about a patient?s prognosis. Objective: This study applies machine learning methods using real-world user data from the MMP app to predict clinically significant improvements in pain-related outcomes among patients at the Toronto General Hospital Transitional Pain Service. Methods: Information entered into the MMP app by 160 Transitional Pain Service patients over a 1-month period, including profile information, pain records, daily reflections, and clinical questionnaire responses, was used to extract 245 relevant variables, referred to as features, for use in a machine learning model. The machine learning model was developed using logistic regression with recursive feature elimination to predict clinically significant improvements in pain-related pain interference, assessed by the PROMIS Pain Interference 8a v1.0 questionnaire. The model was tuned and the important features were selected using the 10-fold cross-validation method. Leave-one-out cross-validation was used to test the model?s performance. Results: The model predicted patient improvement in pain interference with 79% accuracy and an area under the receiver operating characteristic curve of 0.82. It showed balanced class accuracies between improved and nonimproved patients, with a sensitivity of 0.76 and a specificity of 0.82. Feature importance analysis indicated that all MMP app data, not just clinical questionnaire responses, were key to classifying patient improvement. Conclusions: This study demonstrates that data from a digital health app can be integrated with clinical questionnaire responses in a machine learning model to effectively predict which chronic pain patients will show clinically significant improvement. The findings emphasize the potential of machine learning methods in real-world clinical settings to improve personalized treatment plans and patient outcomes. UR - https://medinform.jmir.org/2025/1/e67178 UR - http://dx.doi.org/10.2196/67178 ID - info:doi/10.2196/67178 ER - TY - JOUR AU - Rafiei, Mahdie AU - Das, Supratim AU - Bakhtiari, Mohammad AU - Roos, Maria Ewa AU - Skou, T. Søren AU - Grønne, T. Dorte AU - Baumbach, Jan AU - Baumbach, Linda PY - 2025/3/21 TI - Personalized Predictions for Changes in Knee Pain Among Patients With Osteoarthritis Participating in Supervised Exercise and Education: Prognostic Model Study JO - JMIR Rehabil Assist Technol SP - e60162 VL - 12 KW - osteoarthritis KW - prediction KW - pain intensity KW - exercise therapy KW - machine learning N2 - Background: Knee osteoarthritis (OA) is a common chronic condition that impairs mobility and diminishes quality of life. Despite the proven benefits of exercise therapy and patient education in managing OA pain and functional limitations, these strategies are often underused. To motivate and enhance patient engagement, personalized outcome prediction models can be used. However, the accuracy of existing models in predicting changes in knee pain outcomes remains insufficiently examined. Objective: This study aims to validate existing models and introduce a concise personalized model predicting changes in knee pain from before to after participating in a supervised patient education and exercise therapy program (GLA:D) among patients with knee OA. Methods: Our prediction models leverage self-reported patient information and functional measures. To refine the number of variables, we evaluated the variable importance and applied clinical reasoning. We trained random forest regression models and compared the rate of true predictions of our models with those using average values. In supplementary analyses, we additionally considered recently added variables to the GLA:D registry. Results: We evaluated the performance of a full, continuous, and concise model including all 34 variables, all 11 continuous variables, and the 6 most predictive variables, respectively. All three models performed similarly and were comparable to the existing model, with R2 values of 0.31?0.32 and root-mean-squared errors of 18.65?18.85?despite our increased sample size. Allowing a deviation of 15 (visual analog scale) points from the true change in pain, our concise model correctly estimated the change in pain in 58% of cases, while using average values that resulted in 51% accuracy. Our supplementary analysis led to similar outcomes. Conclusions: Our concise personalized prediction model provides more often accurate predictions for changes in knee pain after the GLA:D program than using average pain improvement values. Neither the increase in sample size nor the inclusion of additional variables improved previous models. Based on current knowledge and available data, no better predictions are possible. Guidance is needed on when a model?s performance is good enough for clinical practice use. UR - https://rehab.jmir.org/2025/1/e60162 UR - http://dx.doi.org/10.2196/60162 ID - info:doi/10.2196/60162 ER - TY - JOUR AU - Zhu, Beiyao AU - Zhu, Dian AU - Xue, Xiao'ao AU - Yang, Hongyi AU - Zhang, Shurong PY - 2025/3/19 TI - Behavioral Therapy?Based Digital Interventions for Treating Osteoarthritis: Systematic Review and Meta-Analysis JO - J Med Internet Res SP - e56227 VL - 27 KW - osteoarthritis KW - digital intervention KW - behavioral therapy KW - treatment KW - systematic review KW - meta-analysis KW - pain KW - impairment KW - quality of life KW - socioeconomic burden KW - psychotherapy-based digital intervention KW - patient KW - pain reduction N2 - Background: Osteoarthritis (OA) is characterized by pain, functional impairments, muscle weakness, and joint stiffness. Since OA heightens reliance on heath care resources and exacerbates socioeconomic burden, remote OA rehabilitation using digital technologies is rapidly evolving. Objective: The aim of this study was to analyze the efficacy of behavioral therapy?based digital interventions for patients with OA. Methods: This study is a systematic review of randomized controlled trials (RCTs) that assessed the effects of behavioral therapy?based digital intervention tools for OA. These RCTs were searched from inception to June 2023 in the Web of Science, Embase, Cochrane Library, Ovid, and PubMed databases. Results: Ten eligible RCTs comprising 1895 patients with OA were included. Digital tools based on either cognitive behavioral therapy (CBT) or behavior change technique (BCT) were investigated. All studies demonstrated low-to-moderate effects on pain reduction in the short term (standardized mean difference [SMD] ?0.20, 95% CI ?0.35 to ?0.05). Six studies reported improvement in physical function (SMD ?0.20, 95% CI ?0.41 to 0.00), and 5 confirmed increased pain self-efficacy (SMD 0.22, 95% CI 0.02-0.42). In subgroup analysis, compared with CBT, BCT-based digital interventions demonstrated their effects on pain reduction (SMD ?0.25, 95% CI ?0.49 to 0.00) and physical function (SMD ?0.26, 95% CI ?0.54 to ?0.01) in the short term. In addition, physiotherapist involvement in treatment had a positive effect on pain control (SMD ?0.14, 95% CI ?0.27 to ?0.02). Furthermore, web-based digital tools improved physical function in the short term (SMD ?0.28, 95% CI ?0.54 to ?0.01). Conclusions: Moderate- and low-quality evidence supported that behavioral therapy?based digital tools improved pain intensity, physical function, and self-efficacy in the short term. However, affective interactions between patients and professionals may affect the clinical outcomes. Trial Registration: PROSPERO CRD42023430716; https://tinyurl.com/yc49vzyy UR - https://www.jmir.org/2025/1/e56227 UR - http://dx.doi.org/10.2196/56227 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/56227 ER - TY - JOUR AU - Wang, Chenxi AU - Gao, Lanqi AU - Zhang, Chuan AU - Li, Jun AU - Liu, Jixin PY - 2025/3/19 TI - Neurobiological Mechanisms of Enhanced Pain-Relieving Transcutaneous Electrical Nerve Stimulation via Visuo-Tactile Stimulation in Immersive Virtual Reality: Randomized Controlled Trial JO - J Med Internet Res SP - e63137 VL - 27 KW - pain KW - pain-relieving KW - transcutaneous electrical nerve stimulation KW - virtual reality KW - electroencephalography N2 - Background: Enhancing the effectiveness of current pain relief strategies is a persistent clinical challenge. Although transcutaneous electrical nerve stimulation (TENS) is used in various painful conditions, its effectiveness may decline over time, requiring additional pain management strategies. Immersive virtual reality (VR) with personalized visuo-tactile stimulation has demonstrated analgesic properties. Nevertheless, whether visuo-tactile stimulation can enhance the pain-relieving outcomes of TENS and its underlying neurophysiological mechanisms remains largely unknown. Objective: The study aims to investigate whether the integration of visuo-tactile stimulation with TENS can enhance the pain-relieving outcomes of TENS alone, and we also aim to explore the brain mechanisms underlying the analgesic effect of this integrated intervention. Methods: In this study, 75 healthy participants were enrolled and randomly assigned to 1 of 3 groups: congruent TENS-VR (TENS-ConVR) and 2 control groups (incongruent TENS-VR [TENS-InVR] and TENS alone). In the context of TENS-ConVR, we combined TENS and VR by connecting TENS-induced paresthesia with personalized visual bodily feedback. The visual feedback was designed to align with the spatiotemporal patterns of the paresthesia induced by TENS. A pain rating task and a 32-channel electroencephalography were applied. Results: Two-way ANOVAs showed that TENS-ConVR exhibited a statistically greater reduction in pain rating (F1,48=6.84; P=.01) and N2 amplitude (F1,48=5.69; P=.02) to high-intensity pain stimuli before and after stimulation than TENS alone. The reduction of brain activity was stronger in participants who reported stronger pain-relieving outcomes. TENS-ConVR reduced the brain oscillation in the gamma band, whereas this result was not found in TENS alone. Conclusions: This study observed that combining TENS and visual stimulation in a single solution could enhance the pain-relieving effect of TENS, which has the potential to improve the effectiveness of current pain management treatments. Trial Registration: Chinese Clinical Trial Registry ChiCTR2500098834; https://www.chictr.org.cn/showprojEN.html?proj=254171 UR - https://www.jmir.org/2025/1/e63137 UR - http://dx.doi.org/10.2196/63137 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63137 ER - TY - JOUR AU - Main, Ashleigh AU - McCartney, Haruno AU - Ibrar, Maryam AU - Muirhead, Fiona AU - Mavroeidi, Alexandra AU - Rai, Kaur Harleen AU - Maguire, Roma PY - 2025/3/18 TI - Patients? Experiences of Digital Health Interventions for the Self-Management of Chronic Pain: Systematic Review and Thematic Synthesis JO - J Med Internet Res SP - e69100 VL - 27 KW - chronic pain KW - digital health KW - digital tool KW - digital health intervention KW - mobile health KW - mHealth KW - eHealth KW - self-management KW - pain management KW - person-centered KW - patient experiences KW - systematic review KW - thematic synthesis N2 - Background: Research regarding the effectiveness of digital health interventions (DHIs) for people living with chronic pain is widely documented, although it is often measured against changes in clinical outcomes. To gain a comprehensive understanding of the full impact of DHIs, it is vital to understand the experience of individuals who are using them. An exploration of qualitative data regarding the experience of people living with chronic pain engaging with DHIs could provide a more in-depth account of how individuals interact and engage with such tools, uncovering the overall impact DHIs can have on the lives of people living with chronic pain. Objective: This qualitative systematic review and thematic synthesis aimed to appraise and synthesize relevant qualitative evidence on patients? experiences of engaging with DHIs for the self-management of chronic pain symptoms. Methods: A systematic literature search of qualitative and mixed methods studies published between 2013 and 2023 was conducted across 6 databases: MEDLINE, PubMed, Embase, CINAHL, PsycINFO, and Scopus. Eligible studies included adult patients aged ?18 years with a chronic pain diagnosis (ie, >12 weeks) reporting on the experience of engaging in a DHI for the self-management of chronic pain. The Critical Appraisal Skills Program checklist for qualitative research was used to appraise each study. Following a 3-step inductive thematic synthesis approach, the researcher performed line-by-line coding of each eligible article to identify descriptive themes. Through iterative evaluation of the descriptive themes, analytical themes that facilitated a deeper understanding of the data were derived. Results: In total, 37 qualitative and mixed methods studies were included in the review. Thematic synthesis revealed three overarching themes encompassing five subthemes: (1) personal growth, with 2 subthemes (gaining new insights and renewed mindset); (2) active involvement, with 3 subthemes (motivation, improved access, and health care decision-making); and (3) connectedness and support. Conclusions: A positive experience with DHIs among people living with chronic pain is achieved through an improved understanding of their condition, greater self-awareness of how symptoms impact their lives, and an increase in motivation to play an active role in their health care. DHIs promote the confidence and independence of people living with chronic pain, as well as facilitate a sense of ongoing support between routine appointments. However, DHIs may disempower people living with chronic pain by placing too much focus on their pain and should be used as an adjunct to existing care as opposed to replacing in-person appointments. To appropriately meet the needs of people living with chronic pain, the content and features of DHIs should be personalized. Development of future DHIs should use a co-design approach involving key stakeholders to ensure the needs of people living with chronic pain are met. Trial Registration: PROSPERO CRD42023445100; https://www.crd.york.ac.uk/PROSPERO/view/CRD42023445100 International Registered Report Identifier (IRRID): RR2-10.2196/52469 UR - https://www.jmir.org/2025/1/e69100 UR - http://dx.doi.org/10.2196/69100 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/69100 ER - TY - JOUR AU - Edwards, A. Karlyn AU - Dildine, C. Troy AU - You, S. Dokyoung AU - Herrick, M. Ashley AU - Darnall, D. Beth AU - Mackey, C. Sean AU - Ziadni, S. Maisa PY - 2025/3/11 TI - Zoom-Delivered Empowered Relief for Chronic Pain: Observational Longitudinal Pilot Study Exploring Feasibility and Pain-Related Outcomes in Patients on Long-Term Opioids JO - JMIR Form Res SP - e68292 VL - 9 KW - Empowered Relief KW - single session KW - chronic pain KW - prescription opioids KW - telehealth KW - daily data KW - pain intensity KW - pain catastrophizing N2 - Background: Patients with chronic pain on long-term opioid therapy often face barriers to accessing effective nonpharmacological treatments, including the burden of multiple sessions, lack of trained clinicians, and travel time. Empowered Relief (ER), a 2-hour, single-session pain relief skills class, can improve pain and quality of life among patients with chronic pain when delivered in person or virtually. Objective: This study examined the impact of Zoom-delivered ER among people with chronic pain on long-term opioid therapy. We assessed (1) the feasibility and acceptability of Zoom-delivered ER; (2) changes in pain and opioid use outcomes at 3 and 6 months after treatment; and (3) daily associations among pain, opioid dose, and the Pain Catastrophizing Scale (PCS) before and after treatment. Methods: During the early COVID-19 pandemic, we conducted an uncontrolled pilot study of a Zoom-delivered ER among 60 adults (n=45, 76% female participants; n=52, 88% White participants) experiencing chronic pain who were receiving daily prescribed opioids (?10 morphine-equivalent daily dose). Participants completed assessments at enrollment, before class, after class, 3 months after treatment, and 6 months after treatment. Furthermore, participants completed 2 daily assessment periods (spanning 14 consecutive days) before and after the class. We used a multilevel modeling approach to examine (1) the raw changes in PCS, average pain intensity, pain interference, and self-reported opioid dose at 3 and 6 months after treatment and (2) daily-level changes in average pain intensity and opioid dose before and after the class. Results: Of the 60 participants enrolled, 41 (68%) attended the class and 24 (59% of the 41 class attendees) reported satisfaction with the Zoom-delivered class. PCS score was significantly reduced at 3 months (?=?3.49, P=.01; Cohen d=0.35) and 6 months after treatment (?=?3.61, P=.01; Cohen d=0.37), and pain intensity was significantly reduced at 3 months (?=?0.56, P=.01; Cohen d=0.39) compared to enrollment. There were no significant reductions in pain interference or opioid dose. Across daily assessments, higher daily pain catastrophizing was associated with worse daily pain (?=.42, P<.001) and higher self-reported opioid use (?=3.14, P<.001); daily pain intensity significantly reduced after the class (?=?.50, P<.001). People taking prescribed opioids as needed trended toward decreasing their daily opioid use after the class (?=?9.31, P=.02), although this result did not survive correction for multiplicity. Conclusions: Improvements to future Zoom-delivered ER iterations are needed to improve feasibility and acceptability among people with chronic pain and daily prescribed opioid use. Despite this, findings show a promising preliminary impact of the intervention on pain outcomes. A larger randomized controlled trial of Zoom-delivered ER among this patient population is currently under way. UR - https://formative.jmir.org/2025/1/e68292 UR - http://dx.doi.org/10.2196/68292 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/68292 ER - TY - JOUR AU - Evans, Kerrie AU - Ko, Jonathan AU - Ceprnja, Dragana AU - Maka, Katherine AU - Beales, Darren AU - Sterling, Michele AU - Bennell, L. Kim AU - Jull, Gwendolen AU - Hodges, W. Paul AU - McKay, J. Marnee AU - Rebbeck, J. Trudy PY - 2025/2/24 TI - Development and Implementation of MyPainHub, a Web-Based Resource for People With Musculoskeletal Conditions and Their Health Care Professionals: Mixed Methods Study JO - JMIR Form Res SP - e63780 VL - 9 KW - clinical pathways KW - allied health KW - self-management KW - health information KW - ehealth KW - co-design N2 - Background: Musculoskeletal conditions, including low back pain (LBP), neck pain, and knee osteoarthritis, are the greatest contributors to years lived with disability worldwide. Resources aiming to aid both patients and health care professionals (HCPs) exist but are poorly implemented and adopted. Objective: We aimed to develop and implement MyPainHub, an evidence-based web-based resource designed to provide comprehensive, credible and accessible information for people with, and HCPs who manage, common musculoskeletal conditions. Methods: This mixed methods study adhered to the New South Wales Translational Research Framework and was evaluated against the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Consultation with key stakeholders (patients, HCPs, researchers, industry, consumer groups, and website developers) informed content, design, features, and functionality. Development then aimed to meet the identified need for a ?one-stop shop??a central location for information about common musculoskeletal conditions tailored to a person?s condition and risk of poor outcomes. MyPainHub was then developed through an iterative process and implementation strategies were tailored to different health care settings. Quantitative and qualitative evaluation occurred with patients and HCPs. Results: In total, 127 stakeholders participated in the development phase; initial consultation with them led to embedding 2 validated screening tools (the Short Form Örebro Musculoskeletal Pain Screening Questionnaire and the Keele STarT MSK tool) in MyPainHub to guide information tailoring for patients based on risk of poor outcomes. Development occurred in parallel and feedback from stakeholders informed design and content including structure, functionality, and phrasing and images to use to emphasize key points. Consultation resulted in information for patients being categorized using key guideline-based messages (general information, your pathway, exercise, and imaging) while information for clinicians was categorized into assessment, management, and prognosis. Implementation occurred in different health care settings with the most effective strategies being interactive education via webinars and workshops. The evaluation phase involved web-based questionnaires (patients: n=44; HCPs: n=29) and focus groups (patients: n=6; HCPs: n=6). Patients and HCPs found MyPainHub user-friendly, acceptable, credible, and potentially able to support self-management. Patient participants identified areas for improvement such as including more specific information on preventative measures and pain relief options. Despite positive feedback, only 35% (10/29) of HCPs used MyPainHub with their patients. HCP participants identified challenges including insufficient training and lack of familiarity with using web-based resources in existing clinical workflows. Following implementation, the information contained on MyPainHub changed knowledge and practice for some patients and HCPs. Conclusions: Following extensive and iterative stakeholder engagement, MyPainHub was developed as an evidence-based web-based resource and perceived by patients and HCPs as user-friendly, credible, and acceptable. Active implementation strategies are required for adoption and implementation and greater training focusing on strategies to implement MyPainHub into clinical practice may be necessary. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619000871145; https://tinyurl.com/438kkyt3 UR - https://formative.jmir.org/2025/1/e63780 UR - http://dx.doi.org/10.2196/63780 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/63780 ER - TY - JOUR AU - Fang, Ruijie AU - Hosseini, Elahe AU - Zhang, Ruoyu AU - Fang, Chongzhou AU - Rafatirad, Setareh AU - Homayoun, Houman PY - 2025/2/24 TI - Survey on Pain Detection Using Machine Learning Models: Narrative Review JO - JMIR AI SP - e53026 VL - 4 KW - pain KW - pain assessment KW - machine learning KW - survey KW - mobile phone N2 - Background: Pain, a leading reason people seek medical care, has become a social issue. Automated pain assessment has seen notable advancements over recent decades, addressing a critical need in both clinical and everyday settings. Objective: The objective of this survey was to provide a comprehensive overview of pain and its mechanisms, to explore existing research on automated pain recognition modalities, and to identify key challenges and future directions in this field. Methods: A literature review was conducted, analyzing studies focused on various modalities for automated pain recognition. The modalities reviewed include facial expressions, physiological signals, audio cues, and pupil dilation, with a focus on their efficacy and application in pain assessment. Results: The survey found that each modality offers unique contributions to automated pain recognition, with facial expressions and physiological signals showing particular promise. However, the reliability and accuracy of these modalities vary, often depending on factors such as individual variability and environmental conditions. Conclusions: While automated pain recognition has progressed considerably, challenges remain in achieving consistent accuracy across diverse populations and contexts. Future research directions are suggested to address these challenges, enhancing the reliability and applicability of automated pain assessment in clinical practice. UR - https://ai.jmir.org/2025/1/e53026 UR - http://dx.doi.org/10.2196/53026 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/53026 ER - TY - JOUR AU - Ding, E. Michael AU - Traiba, Hajar AU - Perez, R. Hector PY - 2025/2/18 TI - Virtual Reality Interventions and Chronic Pain: Scoping Review JO - J Med Internet Res SP - e59922 VL - 27 KW - virtual reality KW - chronic pain KW - scoping review KW - pain management KW - efficacy KW - anxiety disorders KW - mood KW - health condition KW - health intervention KW - adults KW - aging KW - therapeutic KW - descriptive?analytical method KW - monitoring KW - US KW - PRISMA N2 - Background: Virtual reality (VR) interventions have demonstrated efficacy for more than a decade for mood and anxiety disorders and emerging evidence suggests they can reduce pain symptoms in both acute and chronic pain. More recently, these interventions have abounded within the commercial and academic sectors, immersing participants within a virtual environment to confer health benefits to users. VR immersion can facilitate the delivery of health interventions by isolating participants from distractors and stressors in a therapeutic environment. While recent studies of VR interventions have exploded, they are not uniform in approach or device type, limiting generalizability. Recent scoping reviews on VR and chronic pain have focused on specific diseases or limited inquiries to specific interventions or study types. Objective: We conducted a scoping review to generate new knowledge about the sum total of VR studies on chronic pain with specific emphasis on the methods and results of each study, including (1) the type of interventions, (2) outcomes chosen, (3) samples studied, and (4) data generated. Methods: A scoping review was performed on the literature on VR and chronic pain to describe themes associated with the literature to date and identify important gaps and unanswered questions to guide future research. CINAHL [EBSCO] (Cumulative Index to Nursing and Allied Health Literature) and PubMed were queried for the terms ?virtual reality? and ?pain,? providing studies of chronic pain adult participants using VR delivered through headset displays. We included English-language manuscripts that had at least one VR intervention arm with adults with chronic pain. For this analysis, we only included VR interventions that were immersive (ie, using headsets). Non?study reports, studies with no specific chronic pain component, those not involving adults, and those using VR as part of a comprehensive rehabilitation program were excluded. A descriptive analytical method was used to extract data, compare studies, and contextualize the presented outcomes. Articles were categorized into several themes including the type of intervention, outcomes chosen, participant characteristics, degree to which immersion was achieved, and adverse effect monitoring and reporting. Results: A total of 36 articles were included in our analysis. We summarize the literature using 5 themes: (1) heterogeneity of chronic pain types, (2) highly variable intervention types, (3) highly variable secondary and exploratory outcomes, (4) immersion was highly variable between studies and not systemically explored in many articles, and (5) side effect monitoring was limited. Conclusions: The literature on VR in chronic pain is highly variable and lacks theoretical rigor. While there is emerging evidence that supports VR use in a wide variety of health conditions including chronic pain, future research should focus on producing theoretically rigorous work that focuses on mechanisms and that systematically assesses side effects to generate robust generalizable knowledge. UR - https://www.jmir.org/2025/1/e59922 UR - http://dx.doi.org/10.2196/59922 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/59922 ER - TY - JOUR AU - Griefahn, Annika AU - Avermann, Florian AU - Zalpour, Christoff AU - Marshall, Percy Robert AU - Cordon Morillas, Inés AU - Luedtke, Kerstin PY - 2025/2/18 TI - Exploring the Effect of an 8-Week AI-Composed Exercise Program on Pain Intensity and Well-Being in Patients With Spinal Pain: Retrospective Cohort Analysis JO - JMIR Form Res SP - e57826 VL - 9 KW - exercise KW - mHealth KW - app engagement KW - spinal pain KW - artificial intelligence KW - AI KW - intensity KW - well-being KW - mobile health KW - apps KW - applications KW - retrospective analysis KW - physical activity KW - adults KW - questionnaire N2 - Background: Spinal pain, one of the most common musculoskeletal disorders (MSDs), significantly impacts the quality of life due to chronic pain and disability. Physical activity has shown promise in managing spinal pain, although optimizing adherence to exercise remains a challenge. The digital development of artificial intelligence (AI)-driven applications offers a possibility for guiding and supporting patients with MSDs in their daily lives. Objective: The trial aimed to investigate the effect of an 8-week AI-composed exercise program on pain intensity and well-being in patients with spinal pain. It also examined the relationship between exercise frequency, pain intensity, and well-being. In addition, app usage frequency was examined as a proxy for app engagement. Methods: Data from users who met the inclusion criteria were collected retrospectively from the medicalmotion app between January 1, 2020, and June 30, 2023. The intervention involved the use of the medicalmotion app, which provides 3?5 personalized exercises for each session based on individual user data. The primary outcomes assessed pain intensity and well-being using the numeric rating scale (NRS) and the Likert scale. Data were collected at baseline (t0), 4 weeks (t1), and 8 weeks (t2). The correlation between exercise frequency, pain intensity, and well-being was analyzed as a secondary outcome. In addition, average session length and frequency were measured to determine app engagement. Statistical analysis included ANOVA and Spearman correlation analysis. Results: The study included 379 participants with a mean age of 50.96 (SD 12.22) years. At t2, there was a significant reduction of 1.78 points on the NRS (P<.001). The score on the Likert scale for well-being improved by 3.11 points after 8 weeks. Pain intensity showed a negative correlation with the number of daily exercises performed at t1 and t2. Well-being had a small negative correlation with the average number of exercises performed per day. The average number of exercises performed per day was 3.58. The average session length was approximately 10 minutes, and the average interaction with the app was 49.2% (n=27.6 days) of the 56 available days. Conclusions: Overall, the study demonstrates that an app-based intervention program can substantially reduce pain intensity and increase well-being in patients with spinal pain. This retrospective study showed that an app that digitizes multidisciplinary rehabilitation for the self-management of spinal pain significantly reduced user-reported pain intensity in a preselected population of app users. Trial Registration: OSF Registries osf.io/kjhef; https://osf.io/kjhef UR - https://formative.jmir.org/2025/1/e57826 UR - http://dx.doi.org/10.2196/57826 ID - info:doi/10.2196/57826 ER - TY - JOUR AU - Sirohi, Diksha AU - Ng, HM Cecilia AU - Bidargaddi, Niranjan AU - Slater, Helen AU - Parker, Melissa AU - Hull, Louise M. AU - O'Hara, Rebecca PY - 2025/2/7 TI - Good-Quality mHealth Apps for Endometriosis Care: Systematic Search JO - J Med Internet Res SP - e49654 VL - 27 KW - adenomyosis KW - endometriosis KW - m-health apps KW - mobile apps KW - digital health KW - pelvic pain KW - self-learning KW - clinicians KW - mHealth KW - application KW - endometriomas KW - chocolate cysts KW - uterus KW - womb KW - pain management KW - women's health KW - mobile phone N2 - Background: Mobile health (mHealth) apps are increasingly being used by community members to track symptoms and manage endometriosis. In addition, clinicians use mHealth apps for continued medical education and clinical decision-making and recommend good-quality apps to patients. However, poor-quality apps can spread misinformation or provide recommendations that are not evidence-based. Therefore, a critical evaluation is needed to assess and recommend good-quality endometriosis mHealth apps. Objective: This study aimed to evaluate the quality and provide recommendations for good quality endometriosis mHealth apps for the community and clinicians. Methods: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines informed the search of mHealth apps on the Google Play Store and Apple App Store. The search terms included ?endometriosis,? ?adenomyosis,? and ?pelvic pain.? mHealth apps were eligible if they were (1) related to the search terms, (2) were in the English language, and (3) were available free of cost. Only the free content of the eligible mHealth apps was assessed. ENLIGHT, a validated evaluation tool for mobile and web-based interventions, was used to assess the quality across 7 domains such as usability, visual design, user engagement, content, therapeutic persuasiveness, therapeutic alliance, and general subjective evaluation. mHealth apps with a total score of ?3.5 were classified as ?good? according to the ENLIGHT scoring system and are recommended as good-quality mHealth apps for endometriosis care. Results: In total, 42 mHealth apps were screened, and 19 were included in the quality assessment. A total of 6 good-quality mHealth apps were identified (QENDO, Bearable, Luna for Health, Matilda Health, Branch Health: Pain Management, and CHARLI Health). These apps provided symptom-tracking functions and self-management support. A total of 17 apps were designed for community use, while 2 apps provided a digital endometriosis classification tool to clinicians. Most mHealth apps scored well (?3.5) in the domains of usability (16/19, 84.2%), visual design (14/19, 73.7%), user engagement (11/19, 57.9%), and content (15/19, 78.9%). Few eHealth websites scored well on therapeutic persuasiveness (6/19, 31.6%), therapeutic alliance (9/19, 47.4%), and general subjective evaluation (6/19, 31.6%). Conclusions: Although time and geographical location can influence the search results, we identified 6 ?good-quality? endometriosis mHealth apps that can be recommended to the endometriosis community. mHealth apps designed for community use should evaluate their effectiveness on user?s endometriosis knowledge, self-recommended management strategies, pain self-efficacy, user satisfaction, and user quality of life. Digital technology should be leveraged to develop mHealth apps for clinicians that contribute to continued medical education and assist clinical decision-making in endometriosis management. Factors that enhance usability, visual design, therapeutic persuasiveness, and therapeutic alliance should be incorporated to ensure successful and long-term uptake of mHealth apps. Trial Registration: PROSPERO CRD42020185475; https://tinyurl.com/384dkkmj UR - https://www.jmir.org/2025/1/e49654 UR - http://dx.doi.org/10.2196/49654 UR - http://www.ncbi.nlm.nih.gov/pubmed/39918848 ID - info:doi/10.2196/49654 ER - TY - JOUR AU - Elphinston, A. Rachel AU - Pager, Sue AU - Brown, Kelly AU - Sterling, Michele AU - Fatehi, Farhad AU - Gray, Paul AU - Hipper, Linda AU - Cahill, Lauren AU - Connor, P. Jason PY - 2025/1/30 TI - Co-Designing a Digital Brief Intervention to Reduce the Risk of Prescription Opioid?Related Harm Among People With Chronic Noncancer Pain: Qualitative Analysis of Patient Lived Experiences JO - JMIR Form Res SP - e57208 VL - 9 KW - chronic noncancer pain KW - prescription opioid use KW - brief intervention KW - co-design KW - patient partners KW - lived experience KW - qualitative KW - digital health N2 - Background: Opioid medications are important for pain management, but many patients progress to unsafe medication use. With few personalized and accessible behavioral treatment options to reduce potential opioid-related harm, new and innovative patient-centered approaches are urgently needed to fill this gap. Objective: This study involved the first phase of co-designing a digital brief intervention to reduce the risk of opioid-related harm by investigating the lived experience of chronic noncancer pain (CNCP) in treatment-seeking patients, with a particular focus on opioid therapy experiences. Methods: Eligible patients were those aged between 18 and 70 years with CNCP at a clinically significant level of intensity (a score of ?4 of 10). Purposive sampling was used to engage patients on public hospital waitlists via mail or through the treating medical specialist. Participants (N=18; n=10 women; mean age 49.5 years, SD 11.50) completed semistructured telephone interviews. Interviews were transcribed verbatim, thematically analyzed using grounded theory, and member checked by patients. Results: Eight overarching themes were found, listed in the order of their prominence from most to least prominent: limited treatment collaboration and partnership; limited biopsychosocial understanding of pain; continued opioid use when benefits do not outweigh harms; a trial-and-error approach to opioid use; cycles of hopefulness and hopelessness; diagnostic uncertainty; significant negative impacts tied to loss; and complexity of pain and opioid use journeys. Conclusions: The findings of this study advance progress in co-designing digital brief interventions by actively engaging patient partners in their lived experiences of chronic pain and use of prescription opioid medications. The key recommendations proposed should guide the development of personalized solutions to address the complex care needs of patients with CNCP. UR - https://formative.jmir.org/2025/1/e57208 UR - http://dx.doi.org/10.2196/57208 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/57208 ER - TY - JOUR AU - Subramanian, Ajan AU - Cao, Rui AU - Naeini, Kasaeyan Emad AU - Aqajari, Hossein Seyed Amir AU - Hughes, D. Thomas AU - Calderon, Michael-David AU - Zheng, Kai AU - Dutt, Nikil AU - Liljeberg, Pasi AU - Salanterä, Sanna AU - Nelson, M. Ariana AU - Rahmani, M. Amir PY - 2025/1/27 TI - Multimodal Pain Recognition in Postoperative Patients: Machine Learning Approach JO - JMIR Form Res SP - e67969 VL - 9 KW - pain intensity recognition KW - multimodal information fusion KW - signal processing KW - weak supervision KW - health care KW - pain intensity KW - pain recognition KW - machine learning approach KW - acute pain KW - pain assessment KW - behavioral pain KW - pain measurement KW - pain monitoring KW - multimodal machine learning?based framework KW - machine learning?based framework KW - electrocardiogram KW - electromyogram KW - electrodermal activity KW - self-reported pain level KW - clinical pain management N2 - Background: Acute pain management is critical in postoperative care, especially in vulnerable patient populations that may be unable to self-report pain levels effectively. Current methods of pain assessment often rely on subjective patient reports or behavioral pain observation tools, which can lead to inconsistencies in pain management. Multimodal pain assessment, integrating physiological and behavioral data, presents an opportunity to create more objective and accurate pain measurement systems. However, most previous work has focused on healthy subjects in controlled environments, with limited attention to real-world postoperative pain scenarios. This gap necessitates the development of robust, multimodal approaches capable of addressing the unique challenges associated with assessing pain in clinical settings, where factors like motion artifacts, imbalanced label distribution, and sparse data further complicate pain monitoring. Objective: This study aimed to develop and evaluate a multimodal machine learning?based framework for the objective assessment of pain in postoperative patients in real clinical settings using biosignals such as electrocardiogram, electromyogram, electrodermal activity, and respiration rate (RR) signals. Methods: The iHurt study was conducted on 25 postoperative patients at the University of California, Irvine Medical Center. The study captured multimodal biosignals during light physical activities, with concurrent self-reported pain levels using the Numerical Rating Scale. Data preprocessing involved noise filtering, feature extraction, and combining handcrafted and automatic features through convolutional and long-short-term memory autoencoders. Machine learning classifiers, including support vector machine, random forest, adaptive boosting, and k-nearest neighbors, were trained using weak supervision and minority oversampling to handle sparse and imbalanced pain labels. Pain levels were categorized into baseline and 3 levels of pain intensity (1-3). Results: The multimodal pain recognition models achieved an average balanced accuracy of over 80% across the different pain levels. RR models consistently outperformed other single modalities, particularly for lower pain intensities, while facial muscle activity (electromyogram) was most effective for distinguishing higher pain intensities. Although single-modality models, especially RR, generally provided higher performance compared to multimodal approaches, our multimodal framework still delivered results that surpassed most previous works in terms of overall accuracy. Conclusions: This study presents a novel, multimodal machine learning framework for objective pain recognition in postoperative patients. The results highlight the potential of integrating multiple biosignal modalities for more accurate pain assessment, with particular value in real-world clinical settings. UR - https://formative.jmir.org/2025/1/e67969 UR - http://dx.doi.org/10.2196/67969 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/67969 ER - TY - JOUR AU - Holley, Dan AU - Brooks, Amanda AU - Hartz, Matthew AU - Rao, Sudhir AU - Zaubler, Thomas PY - 2025/1/10 TI - mHealth-Augmented Care for Reducing Depression Symptom Severity Among Patients With Chronic Pain: Exploratory, Retrospective Cohort Study JO - JMIR Mhealth Uhealth SP - e52764 VL - 13 KW - mHealth KW - mobile health KW - app KW - behavioral health care KW - depression KW - mental health KW - screening KW - pain KW - chronic pain KW - psychiatric screenings KW - digital health care KW - psychiatry KW - psychiatric KW - longitudinal KW - assessment KW - behavioral KW - self-help KW - integrated KW - comorbidity KW - augmented care N2 - Background: Depression and chronic pain are commonly comorbid, mutually reinforcing, and debilitating. Emerging approaches to mobile behavioral health care (mHealth) promise to improve outcomes for patients with comorbid depression and chronic pain by integrating with existing care models to bolster support and continuity between clinical visits; however, the evidence base supporting the use of mHealth to augment care for this patient population is limited. Objective: To develop an evidence base that sets the stage for future research, we aimed to explore the associations between changes in depression severity and various integrated care models, with and without mHealth augmentation, among patients with comorbid depression and nonmalignant chronic pain. Methods: Our team leveraged retrospective, real-world data from 3837 patients with comorbid depression and nonmalignant chronic pain who received integrated behavioral health care (IBH) at a subspecialty pain clinic. We analyzed one IBH-only, non-mHealth cohort (n=2765), an mHealth-augmented cohort (n=844), and a collaborative care (CoCM)+mHealth cohort (n=136), which were supported by the NeuroFlow mHealth platform, and a pre-CoCM mHealth cohort (n=92), which was supported by the mHealth platform for 3 months prior to beginning the chronic pain treatment. We evaluated changes in depression severity between treatment cohorts via longitudinal analyses of both clinician- and mHealth-administered Patient Health Questionnaire-9 (PHQ-9) assessments. Results: mHealth-augmented integrated care led to significantly greater proportions of patients reaching clinical benchmarks for reduction (725/844, 86% vs 2112/2765, 76%), response (689/844, 82% vs 2027/2765, 73%), and remission (629/844, 75% vs 1919/2765, 69%) compared with integrated care alone. Furthermore, hierarchical regression modeling revealed that patients who received mHealth-augmented psychiatric CoCM experienced the greatest sustained reductions in on-average depression severity compared with other cohorts, irrespective of clinical benchmarks. In addition, patients who engaged with an mHealth platform before entering CoCM experienced a 7.2% reduction in average depression severity before starting CoCM treatment. Conclusions: Our findings suggest that mHealth platforms have the potential to improve treatment outcomes for patients with comorbid chronic pain and depression by providing remote measurement?based care, tailored interventions, and improved continuity between appointments. Moreover, our study set the stage for further research, including randomized controlled trials to evaluate causal relationships between mHealth engagement and treatment outcomes in integrated care settings. UR - https://mhealth.jmir.org/2025/1/e52764 UR - http://dx.doi.org/10.2196/52764 ID - info:doi/10.2196/52764 ER - TY - JOUR AU - Sang, Ling AU - Zheng, Bixin AU - Zeng, Xianzheng AU - Liu, Huizhen AU - Jiang, Qing AU - Liu, Maotong AU - Zhu, Chenyu AU - Wang, Maoying AU - Yi, Zengwei AU - Song, Keyu AU - Song, Li PY - 2024/12/30 TI - Effectiveness of Outpatient Chronic Pain Management for Middle-Aged Patients by Internet Hospitals: Retrospective Cohort Study JO - JMIR Med Inform SP - e54975 VL - 12 KW - chronic pain management KW - internet hospital KW - physical hospital KW - quality of life KW - outpatient care KW - telemedicine KW - digital health N2 - Background: Chronic pain is widespread and carries a heavy disease burden, and there is a lack of effective outpatient pain management. As an emerging internet medical platform in China, internet hospitals have been successfully applied for the management of chronic diseases. There are also a certain number of patients with chronic pain that use internet hospitals for pain management. However, no studies have investigated the effectiveness of pain management via internet hospitals. Objective: The aim of this retrospective cohort study was to explore the effectiveness of chronic pain management by internet hospitals and their advantages and disadvantages compared to traditional physical hospital visits. Methods: This was a retrospective cohort study. Demographic information such as the patient?s sex, age, and number of visits was obtained from the IT center. During the first and last patient visits, information on outcome variables such as the Brief Pain Inventory (BPI), medical satisfaction, medical costs, and adverse drug events was obtained through a telephone follow-up. All patients with chronic pain who had 3 or more visits (internet or offline) between September 2021, and February 2023, were included. The patients were divided into an internet hospital group and a physical hospital group, according to whether they had web-based or in-person consultations, respectively. To control for confounding variables, propensity score matching was used to match the two groups. Matching variables included age, sex, diagnosis, and number of clinic visits. Results: A total of 122 people in the internet hospital group and 739 people in the physical hospital group met the inclusion criteria. After propensity score matching, 77 patients in each of the two groups were included in the analysis. There was not a significant difference in the quality of life (QOL; QOL assessment was part of the BPI scale) between the internet hospital group and the physical hospital group (P=.80), but the QOL of both groups of patients improved after pain management (internet hospital group: P<.001; physical hospital group: P=.001). There were no significant differences in the pain relief rate (P=.25) or the incidence of adverse events (P=.60) between the two groups. The total cost (P<.001) and treatment-related cost (P<.001) of the physical hospital group were higher than those of the internet hospital group. In addition, the degree of satisfaction in the internet hospital group was greater than that in the physical hospital group (P=.01). Conclusions: Internet hospitals are an effective way of managing chronic pain. They can improve patients? QOL and satisfaction, reduce treatment costs, and can be used as part of a multimodal strategy for chronic pain self-management. UR - https://medinform.jmir.org/2024/1/e54975 UR - http://dx.doi.org/10.2196/54975 ID - info:doi/10.2196/54975 ER - TY - JOUR AU - Funao, Hiroki AU - Momosaki, Ryo AU - Tsujikawa, Mayumi AU - Kawamoto, Eiji AU - Esumi, Ryo AU - Shimaoka, Motomu PY - 2024/12/30 TI - Virtual Reality?Applied Home-Visit Rehabilitation for Patients With Chronic Pain: Protocol for Single-Arm Pre-Post Comparison Study JO - JMIR Res Protoc SP - e58734 VL - 13 KW - chronic pain KW - homebound patient KW - home-visit rehabilitation KW - virtual reality KW - protocol KW - feasibility study KW - VR KW - pain KW - recurrent pain KW - home visit KW - rehabilitation KW - home rehabilitation KW - in-home KW - effective KW - screening KW - VR intervention KW - feasibility KW - alleviate pain N2 - Background: Pain inhibits rehabilitation. In rehabilitation at medical institutions, the usefulness of virtual reality (VR) has been reported in many cases to alleviate pain. In recent years, the demand for home rehabilitation has increased. Unlike in medical situations, the patients targeted for in-home rehabilitation often have chronic pain due to physical and psychosocial factors, and the environment is not specialized for rehabilitation. However, VR might be effective for in-home rehabilitation settings. Objective: This study aims to evaluate the feasibility of applying VR to home-visit rehabilitation for homebound patients with chronic pain. Methods: This study will test the feasibility of VR applied to home-visit rehabilitation for patients with chronic pain. A single-arm pre-post comparison will be conducted to evaluate its feasibility. Screening will be conducted on patients who have given consent to participate in the study, and those who have pain that persists or recurs for more than 3 months and receive home-visit rehabilitation will be enrolled in the study. Baseline measurements will be conducted on study participants before the start of the VR intervention. VR-applied home-visit rehabilitation will be conducted once a week for a total of 10 VR interventions. The primary endpoint is the change in pain from the baseline to the tenth intervention. Pain is a subjective symptom of the study participants and will be subjectively assessed by the Numerical Rating Scale of 11 levels from 0 to 10. Pain as the primary endpoint will be measured at 3-time points per rehabilitation session: before, during, and after the rehabilitation so that changes between time points can be evaluated. Secondary endpoints are heart rate variability, range of motion of the area in the musculoskeletal system where the pain occurs, motivation for rehabilitation, catastrophic thoughts of pain, mood state, quality of life, and interviews. Assessments will be conducted at the baseline, first, fifth, and tenth interventions. After completing the clinical study (10 VR interventions), patients will continue their regular home-visit rehabilitation as usual. Results: Recruitment of participants began on February 22, 2022, and data collection is ongoing as of November 2024. The research results will be published in international peer-reviewed journals and through presentations at national and international conferences. Conclusions: This study will contribute to the development of novel rehabilitation-based solutions for homebound patients who have had difficulty obtaining adequate relief from chronic pain. Future studies will consider conducting randomized controlled trials as clinical trials to validate the efficacy of VR during home-visit rehabilitation for patients with chronic pain. International Registered Report Identifier (IRRID): DERR1-10.2196/58734 UR - https://www.researchprotocols.org/2024/1/e58734 UR - http://dx.doi.org/10.2196/58734 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58734 ER - TY - JOUR AU - Ong, Anthony AU - Wilcox, Kenneth AU - Reid, Carrington M. AU - Wethington, Elaine AU - Cintron, Dakota AU - Addington, Elizabeth AU - Goktas, Selin AU - Moskowitz, Judith PY - 2024/12/10 TI - Targeting Daily Positive Events to Improve Emotional and Functional Well-Being in Adults With Fibromyalgia: Insights From the LARKSPUR Randomized Controlled Trial JO - J Med Internet Res SP - e54678 VL - 26 KW - positive affect KW - chronic pain KW - chronic condition KW - long-term pain KW - positive psychology KW - positive events KW - fibromyalgia KW - mHealth KW - app KW - digital technology KW - digital interventions KW - gerontology KW - geriatrics KW - older adult KW - aging KW - well-being N2 - Background: Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, and cognitive difficulties, affecting individuals across all age groups. Positive affect (PA) interventions have shown promise in enhancing emotional well-being and pain management in patients with diverse chronic pain conditions. However, the efficacy of internet-delivered PA interventions for individuals with fibromyalgia remains understudied. Objective: This randomized controlled trial investigated the efficacy of a web-based PA regulation intervention?Lessons in Affect Regulation to Keep Stress and Pain Under Control (LARKSPUR)?in enhancing emotional and functional well-being among adults with fibromyalgia syndrome. Methods: A total of 95 participants with fibromyalgia syndrome aged 50 years and older (89/95, 94% female) were randomized to one of two fully automated conditions: (1) LARKSPUR (n=49) or (2) emotion reporting/attention control (n=46). At the postintervention and 1-month follow-up time points, participants completed 7 consecutive, end-of-day, web-based reports capturing positive events (PE), pain, fatigue, PA, and negative affect. Results: Compared to control, LARKSPUR resulted in greater improvements in daily affective responsivity to PE at the postintervention time point, including greater reductions in negative affect (bL?bC=?0.06, 95% highest posterior density interval [HPD] ?0.10 to ?0.02) and increases in PA (bL?bC=0.10, 95% HPD 0.02-0.19). Furthermore, across the postintervention and 1-month follow-up time points, LARKSPUR led to greater reductions in pain (bL?bC=?0.20, 95% HPD ?0.36 to ?0.04) and fatigue (bL?bC=?0.24, 95% HPD ?0.41 to ?0.06) following PE. Conclusions: This randomized controlled trial provides initial evidence that a web-based PA skills intervention can enhance emotional well-being and reduce pain and fatigue in aging adults with fibromyalgia. Trial Registration: ClinicalTrials.gov NCT04869345; https://clinicaltrials.gov/study/NCT04869345 UR - https://www.jmir.org/2024/1/e54678 UR - http://dx.doi.org/10.2196/54678 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/54678 ER - TY - JOUR AU - Levey, Nadine AU - Chen, Neal AU - Ditre, Joseph AU - Sylvia, Louisa AU - Mudgal, Chaitanya AU - Bhashyam, Abhiram AU - Garg, Rohit AU - Ring, David AU - Vranceanu, Ana-Maria AU - Bakhshaie, Jafar PY - 2024/12/9 TI - A Web-Based Mind-Body Intervention to Improve Resilience Among Patients With Nontraumatic Painful Upper-Extremity Conditions and Comorbid Risky Substance Use: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e64547 VL - 13 KW - chronic pain KW - upper-extremity conditions KW - psychiatry KW - mindfulness KW - mind-body KW - substance use KW - web-based intervention development N2 - Background: Nontraumatic painful upper-extremity conditions (NPUCs) are largely age-related degenerations that affect the majority of adults. Most patients with NPUCs do not seek medical care and adjust on their own. Among those who do seek care, approximately 20% report risky substance use, defined as a consumption pattern that increases the risk of harm to physical or psychosocial health. In the context of NPUC, risky substance use is associated with more intense pain, emotional distress, disability, and opioid or other substance misuse (ie, cross-tolerance). Consequently, risky substance use is a significant modifiable risk factor for the progression and maintenance of chronic pain-related disability and comorbid psychopathology among patients with NPUCs. Objective: This study aims to develop, adapt, and test the feasibility of the Web-Based Toolkit for Resilient Life Beyond Pain and Substance Use (Web-TIRELESS), a novel, asynchronous, and web-based mind-body intervention aimed at modifying maladaptive pain-coping behaviors in patients with NPUC and comorbid risky substance use. This study illustrates the proposed study design, methodology, and intervention content. Methods: In aim 1, we will conduct live video qualitative interviews (n=20) with care-seeking adult patients with NPUC and comorbid risky substance use to inform the development and refinement of Web-TIRELESS and study procedures. In aim 2, we propose an open pilot study (n=12) of Web-TIRELESS with exit interviews and pre- and postintervention assessments to evaluate the feasibility, credibility, and acceptability of Web-TIRELESS and refine study procedures. Aim 3 consists of a pilot feasibility randomized controlled trial of Web-TIRELESS versus minimally enhanced usual care (n=50), both of which follow a web-based modality, to demonstrate the feasibility of recruitment procedures and data collection, as well as the feasibility, credibility, and acceptability of Web-TIRELESS and the control condition (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. Results: Patient interviews (aim 1) concluded in May 2024 and qualitative analysis is expected to be completed in September 2024. Completion of aim 2 (data collection and analysis) is expected by June 2025. The completion of aim 3 and other study-related operations is anticipated by June 2027. Conclusions: We will develop and test Web-TIRELESS, the first asynchronous mind-body intervention specifically adapted to enhance resilience in response to chronic pain among individuals with NPUCs and comorbid risky substance use. Results from this 3-aim study (feasibility, acceptability, and satisfaction of Web-TIRELESS) will be leveraged to inform a future efficacy randomized controlled trial of Web-TIRELESS versus the minimally enhanced usual care. Trial Registration: ClinicalTrials.gov NCT06366633; https://clinicaltrials.gov/study/NCT06366633 International Registered Report Identifier (IRRID): DERR1-10.2196/64547 UR - https://www.researchprotocols.org/2024/1/e64547 UR - http://dx.doi.org/10.2196/64547 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64547 ER - TY - JOUR AU - Groenveld, D. Tjitske AU - Smits, GM Indy AU - Scholten, Naomi AU - de Vries, Marjan AU - van Goor, Harry AU - Stirler, MA Vincent PY - 2024/12/9 TI - Pulmonary and Physical Virtual Reality Exercises for Patients With Blunt Chest Trauma: Randomized Clinical Trial JO - JMIR Serious Games SP - e54389 VL - 12 KW - virtual reality KW - pain KW - pulmonary KW - chest trauma KW - blunt thorax trauma KW - pain relief KW - breathing KW - mobilization KW - randomized clinical trial KW - clinicians KW - rehabilitation KW - physical activity KW - exercise KW - interview N2 - Background: Adequate pain relief, early restoration of breathing, and rapid mobilization pose a clinical challenge in patients with blunt chest trauma. Virtual reality (VR) has the potential to achieve these 3 interrelated treatment objectives with enhanced self-efficacy and autonomy of patients and limited support by clinicians. Objective: This study aimed to assess the effectivity of breathing and physical exercises using VR on the pulmonary recovery of patients with blunt chest trauma at the ward. Methods: A pilot randomized controlled trial was performed. The control group received usual physiotherapy consisting of protocolized breathing exercises (8 times daily for 10 minutes) and physical exercises (2 times daily for 10 minutes). The VR group was instructed to perform these exercises using VR. The primary outcome was vital lung capacity at day 5 or earlier at discharge. Secondary outcomes were patient mobility (time standing, lying, and sitting), clinical outcomes (length of hospital stay, pulmonary complications, transfer to intensive care unit, and readmission within 30 days), pain, activities of daily living, patient-reported outcome measures (satisfaction and quality of recovery). Patient experiences and barriers and facilitators toward implementation were assessed through interviews. Results: The study was prematurely ended due to enrollment failure combined with poor protocol adherence to exercises in both groups. A total of 27 patients were included, of which 19 patients completed 3 or more days. Vital lung capacity at 5 days (or last measurement) was equal between groups with 1830 (SD 591) mL and 1857 (SD 435) mL in the control and VR groups, respectively. No marked differences were observed in secondary outcomes. Patient interviews showed positive attitudes toward the use of VR, describing that visualization of the exercises helped patients to perform the exercises correctly and to continue the exercises for a longer duration. Also, patients experienced the immersiveness of VR as an analgesic. However, patients did not experience added value over usual care and reported that better integration in treatment and the hectic hospital environment could improve the use of the VR exercises. Conclusions: The suitability of patients to use virtual reality therapy (VRx) in a hospital (trauma) ward setting is lower than generally expected. Effective application of VRx requires professional guidance and needs thorough alignment with clinical practice. For future research, we recommend to chart adherence to study protocol before designing a VR clinical trial. Patient-reported experiences need to be prioritized in evaluating VR acceptance, usability, and effectiveness. In line, we recommend performing a systematic analysis (eg, using the technology acceptance model) on the acceptance before pilot or main effectiveness studies. Finally, the eligibility of patients and exclusion of patients due to the inability to use VRx should be routinely reported. Trial Registration: ClinicalTrials.gov NCT05194176; https://tinyurl.com/2bzh4tzx UR - https://games.jmir.org/2024/1/e54389 UR - http://dx.doi.org/10.2196/54389 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/54389 ER - TY - JOUR AU - Lurtz, Josefine AU - C Sauter, Thomas AU - Jacob, Christine PY - 2024/12/4 TI - Factors Impacting the Adoption and Potential Reimbursement of a Virtual Reality Tool for Pain Management in Switzerland: Qualitative Case Study JO - JMIR Hum Factors SP - e59073 VL - 11 KW - eHealth KW - mobile health KW - mHealth KW - digital health KW - reimbursement KW - emergency KW - technology assessment KW - technology adoption KW - implementation KW - VR KW - virtual reality KW - pain KW - experience KW - attitude KW - opinion KW - perception KW - acceptance KW - adoption KW - qualitative KW - interview KW - hospital N2 - Background: Pain and its adequate treatment are an issue in hospitals and emergency departments (EDs). A virtual reality (VR) tool to manage pain could act as a valuable complement to common pharmaceutical analgesics. While efficacy could be shown in previous studies, this does not assure clinical adoption in EDs. Objective: The main aim of this study was to investigate which factors affect the adoption and potential reimbursement of a VR tool for pain management in the ED of a Swiss university hospital. Methods: Key informant interviews were conducted using in-depth semistructured interviews with 11 participants reflecting the perspectives of all the relevant stakeholder groups, including physicians, nurses, patients, health technology providers, and health insurance and reimbursement experts. The interviews were recorded and transcribed, and the extracted data were systematically analyzed using a thematic analysis and narrative synthesis of emergent themes. A consolidated framework for eHealth adoption was used to enable a systematic investigation of the topic and help determine which adoption factors are considered as facilitators or barriers or as not particularly relevant for the tool subject of this study. Results: According to the participants, the three key facilitators are (1) organizational environment; (2) tension for change, ease of use, and demonstrability; and (3) employee engagement. Further, the three key barriers to adoption are (1) workload, (2) changes in clinical workflow and habit, and (3) reimbursement. Conclusions: This study concludes that the adoption of a VR tool for pain management in the ED of the hospital subject of this study, although benefiting from a high tension for change in pain and workload management, is highly dependent on the respective organizational environment, engagement of the clinical staff, and reimbursement considerations. While tailored incentive structures and ambassador roles could benefit initial adoption, a change in the reimbursement landscape and further investigation of the positive effects on workflow effectiveness are required to drive long-term adoption. UR - https://humanfactors.jmir.org/2024/1/e59073 UR - http://dx.doi.org/10.2196/59073 ID - info:doi/10.2196/59073 ER - TY - JOUR AU - Sada, Fatos AU - Chivers, Paola AU - Cecelia, Sokol AU - Statovci, Sejdi AU - Ukperaj, Kujtim AU - Hughes, Jeffery AU - Hoti, Kreshnik PY - 2024/12/3 TI - Parental Assessment of Postsurgical Pain in Infants at Home Using Artificial Intelligence?Enabled and Observer-Based Tools: Construct Validity and Clinical Utility Evaluation Study JO - JMIR Pediatr Parent SP - e64669 VL - 7 KW - PainChek Infant KW - Observer-Administered Visual Analog Scale KW - parents KW - infant pain KW - pain assessment KW - circumcision KW - infant home assessment KW - clinical utility KW - construct validity KW - artificial intelligence N2 - Background: Pain assessment in the infant population is challenging owing to their inability to verbalize and hence self-report pain. Currently, there is a paucity of data on how parents identify and manage this pain at home using standardized pain assessment tools. Objective: This study aimed to explore parents? assessment and intervention of pain in their infants at home following same-day surgery, using standardized pain assessment tools. Methods: This prospective study initially recruited 109 infant boys undergoing circumcision (same-day surgery). To assess pain at home over 3 days after surgery, parents using iOS devices were assigned to use the PainChek Infant tool, which is a point-of-care artificial intelligence?enabled tool, while parents using Android devices were assigned to use the Observer-Administered Visual Analog Scale (ObsVAS) tool. Chi-square analysis compared the intervention undertaken and pain presence. Generalized estimating equations were used to evaluate outcomes related to construct validity and clinical utility. Receiver operating characteristic analysis assessed pain score cutoffs in relation to the intervention used. Results: A total of 69 parents completed postsurgery pain assessments at home and returned their pain diaries. Of these 69 parents, 24 used ObsVAS and 45 used PainChek Infant. Feeding alone and feeding with medication were the most common pain interventions. Pain presence over time reduced. In the presence of pain, an intervention was likely to be administered (?22=21.4; P<.001), with a medicinal intervention being 12.6 (95% CI 4.3-37.0; P<.001) times more likely and a nonmedicinal intervention being 5.2 (95% CI 1.8-14.6; P=.002) times more likely than no intervention. In the presence of intervention, score cutoff values were ?2 for PainChek Infant and ?20 for ObsVAS. A significant effect between the use of the pain instrument (?21=7.2, P=.007) and intervention (?22=43.4, P<.001) was found, supporting the construct validity of both instruments. Standardized pain scores were the highest when a medicinal intervention was undertaken (estimated marginal mean [EMM]=34.2%), followed by a nonmedicinal intervention (EMM=23.5%) and no intervention (EMM=11.2%). Similar trends were seen for both pain instruments. Pain was reduced in 94.5% (224/237) of assessments where parents undertook an intervention. In 75.1% (178/237) of assessments indicative of pain, the score changed from pain to no pain, with PainChek Infant assessments more likely to report this change (odds ratio 4.1, 95% CI 1.4-12.3) compared with ObsVAS assessments. Conclusions: The use of standardized pain assessment instruments by parents at home to assess pain in their infants can inform their decision-making regarding pain identification and management, including determining the effectiveness of the chosen intervention. In addition to the construct validity and clinical utility of PainChek Infant and ObsVAS in this setting, feeding alone and a combination of feeding with medication use were the key pain intervention strategies used by parents. UR - https://pediatrics.jmir.org/2024/1/e64669 UR - http://dx.doi.org/10.2196/64669 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/64669 ER - TY - JOUR AU - Peña, Jorge AU - Koebner, Ian AU - Weisman, William PY - 2024/11/27 TI - Using Digital Art and Attachment Priming in a Web-Based Serious Game to Reduce Pain and Social Disconnection in Individuals With Chronic Pain and Loneliness: Randomized Controlled Trial JO - JMIR Serious Games SP - e52294 VL - 12 KW - pain KW - social disconnection KW - loneliness KW - randomized controlled trial KW - art KW - museums KW - virtual reality KW - serious games KW - virtual art KW - chronic pain and loneliness KW - attachment KW - priming KW - mediation KW - intervention KW - cyberpsychology KW - mental health N2 - Background: Arts engagement using virtual reality and serious games represent promising nonpharmacological self-management treatment approaches to chronic pain. This study is the first randomized controlled trial to explore the impact of a web-based serious game that simulated a visit to an art museum on pain and social disconnection among individuals living with chronic pain and loneliness. Objective: This study aimed to test the joint and separate effects of exposure to digital art and attachment figure priming on pain and social disconnection among individuals living with chronic pain and loneliness. Methods: This randomized controlled trial used a 2 (digital artwork present and absent) × 2 (secure attachment and avoidant attachment prime) repeated measures factorial web-based experimental design with a hanging control condition. Mediation and moderation analyses examined how feelings about the social world triggered by the artwork and frequency of museum visits impacted the effects of the interventions on pain and social disconnection. Results: The results are based on 308 participants. Mean age of the participants was 42.78 (SD 13.11; range 18-76) years, and 60.2% (n=186) were women. Posttest pain was lower than pretest pain for the artwork present (P=.001) and absent (P=.001) conditions. Similarly, posttest pain was lower than pretest pain for the secure (P=.001) and avoidant (P=.001) attachment priming conditions. Relative to the control group, artwork present (P=.001) and absent (P=.01) conditions had decreased posttest pain. The secure (P=.001) and avoidant (P=.001) attachment priming conditions also had lower posttest pain scores relative to the control group. Moreover, social disconnection decreased from pre- to posttest for both the artwork present (P=.04) and the secure attachment priming (P=.002) conditions. Relative to the control group, posttest social disconnection was lower for the artwork present (P=.02) and secure attachment priming condition (P=.03). The artwork-secure attachment (P=.001) and artwork-avoidant attachment (P=.006) conditions had lower posttest pain scores compared with the control group. Social disconnection decreased from pre- to posttest for the artwork-secure attachment (P=.01) and no artwork-secure attachment (P=.05) conditions. Posttest social disconnection was lower for the artwork-secure attachment condition compared with the control group (P=.04). Positive feelings about the social world triggered by artwork exposure and frequency of museum visits in the last year played a mediating and moderating role in these effects. Positive feelings about the social world were associated with decreased pain (B=?.53) and social disconnection (B=?.25), and these effects operated on individuals exposed to digital artwork at low, medium, and high frequency of physical museum visits. Conclusions: Relative to a control group, visiting a web-based art museum reliably decreased pain and social disconnection among individuals living with chronic pain and loneliness. Engaging with digital artwork that triggers positive feelings about the social world may mitigate the burden of chronic pain. Trial Registration: ClinicalTrials.gov NCT05310747; https://clinicaltrials.gov/study/NCT05310747 UR - https://games.jmir.org/2024/1/e52294 UR - http://dx.doi.org/10.2196/52294 ID - info:doi/10.2196/52294 ER - TY - JOUR AU - Wang, Tzu AU - Huang, Yen-Ming AU - Chan, Hsun-Yu PY - 2024/11/8 TI - Exploration of Features of Mobile Applications for Medication Adherence in Asia: Narrative Review JO - J Med Internet Res SP - e60787 VL - 26 KW - Asia KW - adherence KW - application KW - feature KW - medication KW - mobile N2 - Background: Medication is crucial for managing chronic diseases, yet adherence rates are often suboptimal. With advanced integration of IT and mobile internet into health care, mobile apps present a substantial opportunity for improving adherence by incorporating personalized educational, behavioral, and organizational strategies. However, determining the most effective features and functionalities for these apps within the specific health care context in Asia remains a challenge. Objective: We aimed to review the existing literature, focusing on Asian countries, to identify the optimal features of mobile apps that can effectively enhance medication adherence within the unique context of Asian societies. Methods: We conducted a narrative review with the SPIDER (sample, phenomenon of interest, design, evaluation, research type) tool. We identified studies on mobile apps for medication adherence from January 2019 to August 2024 on PubMed and Scopus. Key search terms included ?Asia,? ?chronic disease,? ?app,? ?application,? ?survey,? ?experiment,? ?questionnaire,? ?group,? ?medical adherence,? ?medication adherence,? ?case-control,? ?cohort study,? ?randomized controlled trial,? ?clinical trial,? ?observational study,? ?qualitative research,? ?mixed methods,? and ?analysis,? combined using logical operators ?OR? and ?AND.? The features of mobile apps identified in the studies were evaluated, compared, and summarized based on their disease focuses, developers, target users, features, usability, and use. Results: The study identified 14 mobile apps designed to enhance medication adherence. Of these, 11 were developed by research teams, while 3 were created by commercial companies or hospitals. All the apps incorporated multiple features to support adherence, with reminders being the most common, present in 11 apps. Patient community forums were the least common, appearing in only 1 app. In total, 6 apps provided lifestyle modification functions, offering dietary and exercise recommendations, generating individualized plans, and monitoring progress. In addition, 6 apps featured health data recording and monitoring functions, with 4 allowing users to export and share records with researchers or health care professionals. Many apps included communication features, with 10 enabling feedback from researchers or health care professionals and 7 offering web-based consultation services. Educational content was available in 8 apps, and 7 used motivation strategies to encourage adherence. Six studies showed that mobile apps improved clinical outcomes, such as blood glucose, lipid, and pressure, while reducing adverse events and boosting physical activities. Twelve studies noted positive humanistic effects, including better medication adherence, quality of life, and user satisfaction. Conclusions: This review has identified key components integrated into mobile apps to support medication adherence. However, the lack of government and corporate involvement in their development limits the generalizability of any individual app. Beyond basic reminder functions, features such as multiuser support, feedback mechanisms, web-based consultations, motivational tools, and socialization features hold significant promise for improving medication adherence. Further pragmatic research is necessary to validate the effectiveness of these selected apps in enhancing adherence. UR - https://www.jmir.org/2024/1/e60787 UR - http://dx.doi.org/10.2196/60787 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/60787 ER - TY - JOUR AU - Al-Attar, Mariam AU - Assawamartbunlue, Kesmanee AU - Gandrup, Julie AU - van der Veer, N. Sabine AU - Dixon, G. William PY - 2024/10/28 TI - Exploring the Potential of Electronic Patient-Generated Health Data for Evaluating Treatment Response to Intramuscular Steroids in Rheumatoid Arthritis: Case Series JO - JMIR Form Res SP - e55715 VL - 8 KW - patient-reported outcome measures KW - remote monitoring KW - patient-generated health data KW - mobile health KW - intramuscular steroid injections KW - rheumatoid arthritis KW - app KW - case series KW - symptom tracking KW - pain score N2 - Background: Mobile health devices are increasingly available, presenting exciting opportunities to remotely collect high-frequency, electronic patient-generated health data (ePGHD). This novel data type may provide detailed insights into disease activity outside usual clinical settings. Assessing treatment responses, which can be hampered by the infrequency of appointments and recall bias, is a promising, novel application of ePGHD. Drugs with short treatment effects, such as intramuscular steroid injections, illustrate the challenge, as patients are unlikely to accurately recall treatment responses at follow-ups, which often occur several months later. Retrospective assessment means that responses may be over- or underestimated. High-frequency ePGHD, such as daily, app-collected, patient-reported symptoms between clinic appointments, may bridge this gap. However, the potential of ePGHD remains untapped due to the absence of established definitions for treatment response using ePGHD or established methodological approaches for analyzing this type of data. Objective: This study aims to explore the feasibility of evaluating treatment responses to intramuscular steroid therapy in a case series of patients with rheumatoid arthritis tracking daily symptoms using a smartphone app. Methods: We report a case series of patients who collected ePGHD through the REmote Monitoring Of Rheumatoid Arthritis (REMORA) smartphone app for daily remote symptom tracking. Symptoms were tracked on a 0-10 scale. We described the patients? longitudinal pain scores before and after intramuscular steroid injections. The baseline pain score was calculated as the mean pain score in the 10 days prior to the injection. This was compared to the pain scores in the days following the injection. ?Response? was defined as any improvement from the baseline score on the first day following the injection. The response end time was defined as the first date when the pain score exceeded the pre-steroid baseline. Results: We included 6 patients who, between them, received 9 steroid injections. Average pre-injection pain scores ranged from 3.3 to 9.3. Using our definitions, 7 injections demonstrated a response. Among the responders, the duration of response ranged from 1 to 54 days (median 9, IQR 7-41), average pain score improvement ranged from 0.1 to 5.3 (median 3.3, IQR 2.2-4.0), and maximum pain score improvement ranged from 0.1 to 7.0 (median 4.3, IQR 1.7 to 6.0). Conclusions: This case series demonstrates the feasibility of using ePGHD to evaluate treatment response and is an important exploratory step toward developing more robust methodological approaches for analysis of this novel data type. Issues highlighted by our analysis include the importance of accounting for one-off data points, varying response start times, and confounders such as other medications. Future analysis of ePGHD across a larger population is required to address issues highlighted by our analysis and to develop meaningful consensus definitions for treatment response in time-series data. UR - https://formative.jmir.org/2024/1/e55715 UR - http://dx.doi.org/10.2196/55715 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/55715 ER - TY - JOUR AU - Haun, N. Jolie AU - Fowler, A. Christopher AU - Venkatachalam, H. Hari AU - Alman, C. Amy AU - Ballistrea, M. Lisa AU - Schneider, Tali AU - Benzinger, C. Rachel AU - Melillo, Christine AU - Alexander, B. Neil AU - Klanchar, Angel S. AU - Lapcevic, A. William AU - Bair, J. Matthew AU - Taylor, L. Stephanie AU - Murphy, L. Jennifer AU - French, D. Dustin PY - 2024/10/18 TI - Outcomes of a Remotely Delivered Complementary and Integrative Health Partnered Intervention to Improve Chronic Pain and Posttraumatic Stress Disorder Symptoms: Randomized Controlled Trial JO - J Med Internet Res SP - e57322 VL - 26 KW - posttraumatic stress disorder KW - PTSD KW - pain KW - veteran KW - attrition KW - complementary and integrative health KW - CIH KW - randomized controlled trial KW - chronic pain KW - remote intervention KW - dyad KW - mobile health N2 - Background: Nonpharmacological interventions for veterans are needed to help them manage chronic pain and posttraumatic stress disorder (PTSD) symptoms. Complementary and integrative health (CIH) interventions such as Mission Reconnect (MR) seek to provide veterans with the option of a partnered, self-directed intervention that teaches CIH skills remotely to support symptom management. Objective: The purpose of this study was to describe the physical, psychological, and social outcomes of a self-directed mobile- and web-based CIH intervention for veterans with comorbid chronic pain and PTSD and their partners and qualitatively examine their MR user experience. Methods: A sample of veteran-partner dyads (n=364) were recruited to participate in a mixed methods multisite waitlist control randomized controlled trial to measure physical, psychological, and social outcomes, with pain as the primary outcome and PTSD, depression, stress, sleep, quality of life, and relationships as secondary outcomes. Linear mixed models were constructed for primary and secondary patient-reported outcomes. The quantitative analysis was triangulated using qualitative interviews from a subsample of dyads (n=35) to examine participants? perceptions of their program experience. Results: Dyads were randomized to 2 groups: intervention (MR; 140/364, 38.5%) and waitlist control (136/364, 37.4%). No significant change was observed in overall pain, sleep, PTSD, quality of life, relationship satisfaction, overall self-compassion, or compassion for others. A significant reduction in pain interference in mood (P=.008) and sleep (P=.008) was observed among the veteran MR group that was not observed in the waitlist control group. We also observed a positive effect of the MR intervention on a reduction in negative affect associated with pain (P=.049), but this effect did not exceed the adjusted significance threshold (P=.01). Significant improvements were also observed for partners in the affection (P=.007) and conflict (P=.001) subdomains of the consensus and satisfaction domains. In contrast to quantitative results, qualitative data indicated that intervention impacts included improved sleep and reduced pain, anxiety, and stress and, in contrast to the survey data, overall improvement in PTSD symptoms and social relationships. Participants? overall impressions of MR highlight usability and navigation, perceptions on packaging and content, and barriers to and facilitators of MR use. Conclusions: Adjunctive CIH-based modalities can be delivered using web and mobile apps but should be developed and tailored using established best practices. MR may be beneficial for veterans with pain and PTSD and their partners. Further pragmatic trials and implementation efforts are warranted. Trial Registration: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/study/NCT03593772 International Registered Report Identifier (IRRID): RR2-10.2196/13666 UR - https://www.jmir.org/2024/1/e57322 UR - http://dx.doi.org/10.2196/57322 UR - http://www.ncbi.nlm.nih.gov/pubmed/39422992 ID - info:doi/10.2196/57322 ER - TY - JOUR AU - Elser, Alexander AU - Kopkow, Christian AU - Schäfer, Georg Axel PY - 2024/9/23 TI - Implementation of a Virtual Reality Intervention in Outpatient Physiotherapy for Chronic Pain: Protocol for a Pilot Implementation Study JO - JMIR Res Protoc SP - e58089 VL - 13 KW - chronic pain KW - implementation KW - virtual reality KW - VR KW - physiotherapy KW - virtual reality intervention KW - pain KW - outpatient KW - chronic pain conditions KW - evidence-based N2 - Background: Chronic pain is a global health issue that causes physical, psychological, and social disabilities for patients, as well as high costs for societies. Virtual reality (VR) is a new treatment that provides an opportunity to narrow the gap between clinical practice and recommended care in the use of patient education and behavioral interventions in the outpatient physiotherapy setting. However, there is currently no implementation strategy to integrate VR treatments into this setting. Objective: This protocol outlines a pilot implementation study that aims to (1) identify barriers and facilitators for implementing a VR intervention in outpatient physiotherapy care for people with chronic pain and (2) develop and pilot test an implementation strategy in 5 practices in Germany. Methods: The study consists of 4 phases. The first phase involves adapting the treatment protocol of the VR intervention to the local context of outpatient physiotherapy practices in Germany. The second phase includes the collection of barriers and facilitators through semistructured interviews from physiotherapists and the development of a theory-driven implementation strategy based on the Theoretical Domains framework and the Behavior Change Wheel. This strategy will be applied in the third phase, which will also include a 6-month span of using VR interventions in practices, along with a process evaluation. The fourth phase consists of semistructured interviews to evaluate the developed implementation strategy. Results: The recruitment process and phase 1, including the adaptation of the treatment protocol, have already been completed. We recruited 5 physiotherapy practices in Lower Saxony, Germany, where the VR intervention will be implemented. The collection of barriers and facilitators through semistructured interviews is scheduled to begin in February 2024. Conclusions: This pilot implementation study aims to develop a theory-driven implementation strategy for integrating a VR intervention into outpatient physiotherapy care for people with chronic pain. The identified barriers and facilitators, along with the implementation strategy, will serve as a starting point for future randomized controlled implementation studies in different settings to refine the implementation process and integrate VR interventions into the outpatient care of people with chronic pain. Trial Registration: German Clinical Trials Register DRKS00030862; https://tinyurl.com/3zf7uujx International Registered Report Identifier (IRRID): DERR1-10.2196/58089 UR - https://www.researchprotocols.org/2024/1/e58089 UR - http://dx.doi.org/10.2196/58089 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/58089 ER - TY - JOUR AU - Thomas, Benjamin AU - Barclay, Greg AU - Lo, Angela Wing-Shan AU - Mullan, Judy AU - Mansfield, Kylie PY - 2024/9/4 TI - Dexmedetomidine Versus Midazolam for End-of-Life Sedation and Agitation: Protocol for a Randomized Controlled Trial (The DREAMS Trial) JO - JMIR Res Protoc SP - e55129 VL - 13 KW - palliative KW - sedation KW - delirium KW - dexmedetomidine KW - midazolam KW - antipsychotics KW - deep sedation KW - palliative care KW - sedative KW - adult KW - inpatient KW - Australia KW - quality of life KW - end of life KW - protocol KW - dexmedetomidine for the reduction of end-of-life agitation and for optiMised sedation KW - DREAMS trial KW - DREAMS N2 - Background: Sedation at the end of life is used to relieve distressing symptoms including agitation and delirium. Standard care may include infused benzodiazepines or antipsychotics. These agents often result in deep sedation with loss of interaction with loved ones, which may be distressing. Objective: The DREAMS (Dexmedetomidine for the Reduction of End-of-life Agitation and for optiMised Sedation) trial aimed to compare the sedative and antidelirium effects of the alpha-2 agonist dexmedetomidine, a novel palliative care sedative, compared with midazolam, a benzodiazepine when administered by subcutaneous infusion at the end of life, with doses of both agents targeting lighter, or potentially interactive sedation. Methods: Participants were recruited from adult inpatients admitted for end-of-life care under a palliative care team in regional New South Wales, Australia. Inclusion criteria included patients older than 18 years, with a preference for lighter sedation at the end of life. Exclusion criteria included severe cardiac dysfunction (contraindication to dexmedetomidine). Participants consented and were placed on a treatment-pending list. Upon experiencing terminal deterioration, patients were randomized to either arm 1 (dexmedetomidine) or arm 2 (midazolam) as their treatment arm. These treatments were administered by continuous subcutaneous infusion. The level of consciousness and agitation of the patients were measured by the Richmond Agitation-Sedation Scale?Palliative version and the Memorial Delirium Assessment Score. Richmond Agitation-Sedation Scale?Palliative version assessments were performed by both nursing and medical staff, while Memorial Delirium Assessment Score assessments were carried out by medical staff only. Families and patients were asked to complete, as able, a patient comfort assessment form, to gauge perceptions of distress. Data were collected and matched with the breakthrough medication doses administered, along with qualitative comments in the medical record. In addition, the study tracked symptoms and patient functional status that were recorded as part of the Palliative Care Outcomes Collaborative, a national tracking project for monitoring symptom outcomes in palliative care. Results: The DREAMS trial was funded in May 2020, approved by the ethics committee in November 2020, and started recruiting participants in May 2021. Data collection commenced in May 2021 and is anticipated to continue until December 2024. Publication of results is anticipated from 2024 to 2026. Conclusions: The evidence base for sedative dosing in palliative care for distress and agitation is not robust, with standard care based primarily on clinical experience and not robust scientific evidence. This study is important because it will compare a standard and a novel sedative used in end-of-life treatment. By assessing the potential efficacy and benefits of both, it seeks to optimize the quality of dying by providing targeted sedation that can improve the communication between dying patients and their loved ones. Trial Registration: Australia New Zealand Clinical Trials Register ACTRN12621000052831; https://uat.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380889 International Registered Report Identifier (IRRID): DERR1-10.2196/55129 UR - https://www.researchprotocols.org/2024/1/e55129 UR - http://dx.doi.org/10.2196/55129 UR - http://www.ncbi.nlm.nih.gov/pubmed/39230940 ID - info:doi/10.2196/55129 ER - TY - JOUR AU - Pradhan, Apoorva AU - Wright, A. Eric AU - Hayduk, A. Vanessa AU - Berhane, Juliana AU - Sponenberg, Mallory AU - Webster, Leeann AU - Anderson, Hannah AU - Park, Siyeon AU - Graham, Jove AU - Friedenberg, Scott PY - 2024/8/29 TI - Impact of an Electronic Health Record?Based Interruptive Alert Among Patients With Headaches Seen in Primary Care: Cluster Randomized Controlled Trial JO - JMIR Med Inform SP - e58456 VL - 12 KW - headache management KW - migraine management KW - electronic health record?based alerts KW - primary care KW - clinician decision support tools KW - electronic health record KW - EHR N2 - Background: Headaches, including migraines, are one of the most common causes of disability and account for nearly 20%?30% of referrals from primary care to neurology. In primary care, electronic health record?based alerts offer a mechanism to influence health care provider behaviors, manage neurology referrals, and optimize headache care. Objective: This project aimed to evaluate the impact of an electronic alert implemented in primary care on patients? overall headache management. Methods: We conducted a stratified cluster-randomized study across 38 primary care clinic sites between December 2021 to December 2022 at a large integrated health care delivery system in the United States. Clinics were stratified into 6 blocks based on region and patient-to?health care provider ratios and then 1:1 randomized within each block into either the control or intervention. Health care providers practicing at intervention clinics received an interruptive alert in the electronic health record. The primary end point was a change in headache burden, measured using the Headache Impact Test 6 scale, from baseline to 6 months. Secondary outcomes included changes in headache frequency and intensity, access to care, and resource use. We analyzed the difference-in-differences between the arms at follow-up at the individual patient level. Results: We enrolled 203 adult patients with a confirmed headache diagnosis. At baseline, the average Headache Impact Test 6 scores in each arm were not significantly different (intervention: mean 63, SD 6.9; control: mean 61.8, SD 6.6; P=.21). We observed a significant reduction in the headache burden only in the intervention arm at follow-up (3.5 points; P=.009). The reduction in the headache burden was not statistically different between groups (difference-in-differences estimate ?1.89, 95% CI ?5 to 1.31; P=.25). Similarly, secondary outcomes were not significantly different between groups. Only 11.32% (303/2677) of alerts were acted upon. Conclusions: The use of an interruptive electronic alert did not significantly improve headache outcomes. Low use of alerts by health care providers prompts future alterations of the alert and exploration of alternative approaches. Trial Registration: ClinicalTrials.gov NCT05067725; https://clinicaltrials.gov/study/NCT05067725 UR - https://medinform.jmir.org/2024/1/e58456 UR - http://dx.doi.org/10.2196/58456 ID - info:doi/10.2196/58456 ER - TY - JOUR AU - Cescon, Corrado AU - Landolfi, Giuseppe AU - Bonomi, Niko AU - Derboni, Marco AU - Giuffrida, Vincenzo AU - Rizzoli, Emilio Andrea AU - Maino, Paolo AU - Koetsier, Eva AU - Barbero, Marco PY - 2024/8/27 TI - Automated Pain Spots Recognition Algorithm Provided by a Web Service?Based Platform: Instrument Validation Study JO - JMIR Mhealth Uhealth SP - e53119 VL - 12 KW - pain drawing KW - image processing KW - body charts KW - scan KW - pain KW - draw KW - drawing KW - scanner KW - scanners KW - app KW - apps KW - applications KW - device KW - devices KW - image KW - images KW - smartphone KW - smartphones KW - scale KW - musculoskeletal KW - body chart KW - accuracy KW - reliability KW - accurate KW - reliable KW - picture KW - pictures KW - mobile phone N2 - Background: Understanding the causes and mechanisms underlying musculoskeletal pain is crucial for developing effective treatments and improving patient outcomes. Self-report measures, such as the Pain Drawing Scale, involve individuals rating their level of pain on a scale. In this technique, individuals color the area where they experience pain, and the resulting picture is rated based on the depicted pain intensity. Analyzing pain drawings (PDs) typically involves measuring the size of the pain region. There are several studies focusing on assessing the clinical use of PDs, and now, with the introduction of digital PDs, the usability and reliability of these platforms need validation. Comparative studies between traditional and digital PDs have shown good agreement and reliability. The evolution of PD acquisition over the last 2 decades mirrors the commercialization of digital technologies. However, the pen-on-paper approach seems to be more accepted by patients, but there is currently no standardized method for scanning PDs. Objective: The objective of this study was to evaluate the accuracy of PD analysis performed by a web platform using various digital scanners. The primary goal was to demonstrate that simple and affordable mobile devices can be used to acquire PDs without losing important information. Methods: Two sets of PDs were generated: one with the addition of 216 colored circles and another composed of various red shapes distributed randomly on a frontal view body chart of an adult male. These drawings were then printed in color on A4 sheets, including QR codes at the corners in order to allow automatic alignment, and subsequently scanned using different devices and apps. The scanners used were flatbed scanners of different sizes and prices (professional, portable flatbed, and home printer or scanner), smartphones with varying price ranges, and 6 virtual scanner apps. The acquisitions were made under normal light conditions by the same operator. Results: High-saturation colors, such as red, cyan, magenta, and yellow, were accurately identified by all devices. The percentage error for small, medium, and large pain spots was consistently below 20% for all devices, with smaller values associated with larger areas. In addition, a significant negative correlation was observed between the percentage of error and spot size (R=?0.237; P=.04). The proposed platform proved to be robust and reliable for acquiring paper PDs via a wide range of scanning devices. Conclusions: This study demonstrates that a web platform can accurately analyze PDs acquired through various digital scanners. The findings support the use of simple and cost-effective mobile devices for PD acquisition without compromising the quality of data. Standardizing the scanning process using the proposed platform can contribute to more efficient and consistent PD analysis in clinical and research settings. UR - https://mhealth.jmir.org/2024/1/e53119 UR - http://dx.doi.org/10.2196/53119 ID - info:doi/10.2196/53119 ER - TY - JOUR AU - Lo, Man Hermione Hin AU - Zhu, Mengting AU - Zou, Zihui AU - Wong, Lee Cho AU - Lo, Shan Suzanne Hoi AU - Chung, Chi-Ho Vincent AU - Wong, Yeung-Shan Samuel AU - Sit, Shan Regina Wing PY - 2024/8/19 TI - Immersive and Nonimmersive Virtual Reality?Assisted Active Training in Chronic Musculoskeletal Pain: Systematic Review and Meta-Analysis JO - J Med Internet Res SP - e48787 VL - 26 KW - virtual reality KW - VR KW - physical therapy KW - musculoskeletal KW - pain KW - physiotherapy KW - chronic pain KW - musculoskeletal pain KW - low back pain KW - neck pain KW - osteoarthritis KW - knee pain KW - shoulder pain KW - disability KW - kinesiophobia KW - arthritis KW - systematic KW - review methods KW - review methodology KW - immersive KW - simulation KW - simulations N2 - Background: Virtual reality (VR) in different immersive conditions has been increasingly used as a nonpharmacological method for managing chronic musculoskeletal pain. Objective: We aimed to assess the effectiveness of VR-assisted active training versus conventional exercise or physiotherapy in chronic musculoskeletal pain and to analyze the effects of immersive versus nonimmersive VR on pain outcomes. Methods: This systematic review of randomized control trials (RCTs) searched PubMed, Scopus, and Web of Science databases from inception to June 9, 2024. RCTs comparing adults with chronic musculoskeletal pain receiving VR-assisted training were included. The primary outcome was pain intensity; secondary outcomes included functional disability and kinesiophobia. Available data were pooled in a meta-analysis. Studies were graded using the Cochrane Risk-of-Bias Tool version 2. Results: In total, 28 RCTs including 1114 participants with some concerns for a high risk of bias were identified, and 25 RCTs were included in the meta-analysis. In low back pain, short-term outcomes measured post intervention showed that nonimmersive VR is effective in reducing pain (standardized mean difference [SMD] ?1.79, 95% CI ?2.72 to ?0.87; P<.001), improving disability (SMD ?0.44, 95% CI ?0.72 to ?0.16; P=.002), and kinesiophobia (SMD ?2.94, 95% CI ?5.20 to ?0.68; P=.01). Intermediate-term outcomes measured at 6 months also showed that nonimmersive VR is effective in reducing pain (SMD ?8.15, 95% CI ?15.29 to ?1.01; P=.03), and kinesiophobia (SMD ?4.28, 95% CI ?8.12 to ?0.44; P=.03) compared to conventional active training. For neck pain, immersive VR reduced pain intensity (SMD ?0.55, 95% CI ?1.02 to ?0.08; P=.02) but not disability and kinesiophobia in the short term. No statistical significances were detected for knee pain or other pain regions at all time points. In addition, 2 (8%) studies had a high risk of bias. Conclusions: Both nonimmersive and immersive VR?assisted active training is effective in reducing back and neck pain symptoms. Our study findings suggest that VR is effective in alleviating chronic musculoskeletal pain. Trial Registration: PROSPERO CRD42022302912; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=302912 UR - https://www.jmir.org/2024/1/e48787 UR - http://dx.doi.org/10.2196/48787 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/48787 ER - TY - JOUR AU - Shi, Lin-Hong Jenny AU - Sit, Wing-Shan Regina PY - 2024/8/16 TI - Impact of 25 Years of Mobile Health Tools for Pain Management in Patients With Chronic Musculoskeletal Pain: Systematic Review JO - J Med Internet Res SP - e59358 VL - 26 KW - mHealth KW - mobile health KW - mobile app KW - chronic musculoskeletal pain KW - pain management KW - patient compliance KW - adherence KW - usability KW - feasibility KW - acceptability KW - PRISMA N2 - Background: Mobile technologies are increasingly being used in health care and public health practice for patient communication, monitoring, and education. Mobile health (mHealth) tools have also been used to facilitate adherence to chronic musculoskeletal pain (CMP) management, which is critical to achieving improved pain outcomes, quality of life, and cost-effective health care. Objective: The aim of this systematic review was to evaluate the 25-year trend of the literature on the adherence, usability, feasibility, and acceptability of mHealth interventions in CMP management among patients and health care providers. Methods: We searched the PubMed, Cochrane CENTRAL, MEDLINE, EMBASE, and Web of Science databases for studies assessing the role of mHealth in CMP management from January 1999 to December 2023. Outcomes of interest included the effect of mHealth interventions on patient adherence; pain-specific clinical outcomes after the intervention; and the usability, feasibility, and acceptability of mHealth tools and platforms in chronic pain management among target end users. Results: A total of 89 articles (26,429 participants) were included in the systematic review. Mobile apps were the most commonly used mHealth tools (78/89, 88%) among the included studies, followed by mobile app plus monitor (5/89, 6%), mobile app plus wearable sensor (4/89, 4%), and web-based mobile app plus monitor (1/89, 1%). Usability, feasibility, and acceptability or patient preferences for mHealth interventions were assessed in 26% (23/89) of the studies and observed to be generally high. Overall, 30% (27/89) of the studies used a randomized controlled trial (RCT), cohort, or pilot design to assess the impact of the mHealth intervention on patients? adherence, with significant improvements (all P<.05) observed in 93% (25/27) of these studies. Significant (judged at P<.05) between-group differences were reported in 27 of the 29 (93%) RCTs that measured the effect of mHealth on CMP-specific clinical outcomes. Conclusions: There is great potential for mHealth tools to better facilitate adherence to CMP management, and the current evidence supporting their effectiveness is generally high. Further research should focus on the cost-effectiveness of mHealth interventions for better incorporating these tools into health care practices. Trial Registration: International Prospective Register of Systematic Reviews (PROSPERO) CRD42024524634; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=524634 UR - https://www.jmir.org/2024/1/e59358 UR - http://dx.doi.org/10.2196/59358 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/59358 ER - TY - JOUR AU - Erridge, Simon AU - Troup, Lucy AU - Sodergren, Hans Mikael PY - 2024/8/14 TI - Illicit Cannabis Use to Self-Treat Chronic Health Conditions in the United Kingdom: Cross-Sectional Study JO - JMIR Public Health Surveill SP - e57595 VL - 10 KW - cannabis KW - chronic pain KW - anxiety KW - multiple sclerosis KW - posttraumatic stress disorder KW - PTSD KW - fibromyalgia KW - misuse KW - cannabis misuse KW - cannabis use KW - self-treatment KW - chronic health condition KW - cross-sectional study KW - United Kingdom KW - illicit cannabis KW - adult KW - consumption KW - adults KW - survey KW - cannabis-based KW - medicinal products KW - cannabis-based medicinal products N2 - Background: In 2019, it was estimated that approximately 1.4 million adults in the United Kingdom purchased illicit cannabis to self-treat chronic physical and mental health conditions. This analysis was conducted following the rescheduling of cannabis-based medicinal products (CBMPs) in the United Kingdom but before the first specialist clinics had started treating patients. Objective: The aim of this study was to assess the prevalence of illicit cannabis consumption to treat a medically diagnosed condition following the introduction of specialist clinics that could prescribe legal CBMPs in the United Kingdom. Methods: Adults older than 18 years in the United Kingdom were invited to participate in a cross-sectional survey through YouGov between September 22 and 29, 2022. A series of questions were asked about respondents? medical diagnoses, illicit cannabis use, the cost of purchasing illicit cannabis per month, and basic demographics. The responding sample was weighted to generate a sample representative of the adult population of the United Kingdom. Modeling of population size was conducted based on an adult (18 years or older) population of 53,369,083 according to 2021 national census data. Results: There were 10,965 respondents to the questionnaire, to which weighting was applied. A total of 5700 (51.98%) respondents indicated that they were affected by a chronic health condition. The most reported condition was anxiety (n=1588, 14.48%). Of those enduring health conditions, 364 (6.38%) purchased illicit cannabis to self-treat health conditions. Based on survey responses, it was modeled that 1,770,627 (95% CI 1,073,791?2,467,001) individuals consume illicit cannabis for health conditions across the United Kingdom. In the multivariable logistic regression, the following were associated with an increased likelihood of reporting illicit cannabis use for health reasons?chronic pain, fibromyalgia, posttraumatic stress disorder, multiple sclerosis, other mental health disorders, male sex, younger age, living in London, being unemployed or not working for other reasons, and working part-time (P<.05). Conclusions: This study highlights the scale of illicit cannabis use for health reasons in the United Kingdom and the potential barriers to accessing legally prescribed CBMPs. This is an important step in developing harm reduction policies to transition these individuals, where appropriate, to CBMPs. Such policies are particularly important considering the potential risks from harmful contaminants of illicit cannabis and self-treating a medical condition without clinical oversight. Moreover, it emphasizes the need for further funding of randomized controlled trials and the use of novel methodologies to determine the efficacy of CBMPs and their use in common chronic conditions. UR - https://publichealth.jmir.org/2024/1/e57595 UR - http://dx.doi.org/10.2196/57595 ID - info:doi/10.2196/57595 ER - TY - JOUR AU - Armfield, Nigel AU - Elphinston, Rachel AU - Liimatainen, Jenna AU - Scotti Requena, Simone AU - Eather, Chloe-Emily AU - Edirippulige, Sisira AU - Ritchie, Carrie AU - Robins, Sarah AU - Sterling, Michele PY - 2024/8/14 TI - Development and Use of Mobile Messaging for Individuals With Musculoskeletal Pain Conditions: Scoping Review JO - JMIR Mhealth Uhealth SP - e55625 VL - 12 KW - musculoskeletal KW - pain KW - SMS text messaging KW - mobile health KW - mHealth KW - intervention design KW - design KW - scoping review KW - musculoskeletal pain KW - development KW - mobile messaging KW - behavior change KW - efficacy KW - effectiveness KW - messaging KW - implementation KW - sustainability KW - mobile phone N2 - Background: Population studies show that musculoskeletal conditions are a leading contributor to the total burden of healthy life lost, second only to cancer and with a similar burden to cardiovascular disease. Prioritizing the delivery of effective treatments is necessary, and with the ubiquity of consumer smart devices, the use of digital health interventions is increasing. Messaging is popular and easy to use and has been studied for a range of health-related uses, including health promotion, encouragement of behavior change, and monitoring of disease progression. It may have a useful role to play in the management and self-management of musculoskeletal conditions. Objective: Previous reviews on the use of messaging for people with musculoskeletal conditions have focused on synthesizing evidence of effectiveness from randomized controlled trials. In this review, our objective was to map the musculoskeletal messaging literature more broadly to identify information that may inform the design of future messaging interventions and summarize the current evidence of efficacy, effectiveness, and economics. Methods: Following a prepublished protocol developed using the Joanna Briggs Institute Manual for Evidence Synthesis, we conducted a comprehensive scoping review of the literature (2010-2022; sources: PubMed, CINAHL, Embase, and PsycINFO) related to SMS text messaging and app-based messaging for people with musculoskeletal conditions. We described our findings using tables, plots, and a narrative summary. Results: We identified a total of 8328 papers for screening, of which 50 (0.6%) were included in this review (3/50, 6% previous reviews and 47/50, 94% papers describing 40 primary studies). Rheumatic diseases accounted for the largest proportion of the included primary studies (19/40, 48%), followed by studies on multiple musculoskeletal conditions or pain sites (10/40, 25%), back pain (9/40, 23%), neck pain (1/40, 3%), and ?other? (1/40, 3%). Most studies (33/40, 83%) described interventions intended to promote positive behavior change, typically by encouraging increased physical activity and exercise. The studies evaluated a range of outcomes, including pain, function, quality of life, and medication adherence. Overall, the results either favored messaging interventions or had equivocal outcomes. While the theoretical underpinnings of the interventions were generally well described, only 4% (2/47) of the papers provided comprehensive descriptions of the messaging intervention design and development process. We found no relevant economic evaluations. Conclusions: Messaging has been used for the care and self-management of a range of musculoskeletal conditions with generally favorable outcomes reported. However, with few exceptions, design considerations are poorly described in the literature. Further work is needed to understand and disseminate information about messaging content and message delivery characteristics, such as timing and frequency specifically for people with musculoskeletal conditions. Similarly, further work is needed to understand the economic effects of messaging and practical considerations related to implementation and sustainability. International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2021-048964 UR - https://mhealth.jmir.org/2024/1/e55625 UR - http://dx.doi.org/10.2196/55625 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/55625 ER - TY - JOUR AU - Smits, H. Rachel J. AU - van der Wal, I. Selina E. AU - van Boekel, M. Regina L. AU - Timmerman, Hans AU - Bronkhorst, M. Ewald AU - Abrar, Diana AU - Vissers, P. Kris C. AU - Blaney Davidson, N. Esmeralda AU - Steegers, H. Monique A. PY - 2024/8/9 TI - Sex Differences in Pain Sensitivity in a Dutch Cohort: Cross-Sectional and Web-Based Multidimensional Study JO - J Med Internet Res SP - e53926 VL - 26 KW - pain sensitivity KW - pain sensitivity questionnaire KW - chronic pain KW - digital interventions KW - mobile health KW - film KW - sex KW - Dutch population KW - personalized medicine KW - individualized care N2 - Background: Sex is an important factor influencing the development and treatment of chronic pain, but the extent of its influence is still unclear. Other demographic factors as well as nonpharmacological interventions might influence pain sensitivity differently in men and women. Objective: In this study, we aimed to investigate the influence of sex and other demographic, lifestyle, behavioral, clinical, and environmental factors on pain sensitivity in the Dutch population. Different films were used to investigate how they would impact pain sensitivity and what influence sex and other variables have on the effect of this simple intervention. Methods: We performed a study consisting of 2 parts: (1) a cross-sectional research to investigate pain sensitivity differences between men and women and the influence of other demographic variables on the pain sensitivity in a Dutch cohort and (2) an internet intervention study to determine whether a short film could skew pain sensitivity. Results: All respondents filled in a web-based demographic questionnaire and were randomized into 4 groups. The control group filled in the Pain Sensitivity Questionnaire without watching a preliminary film. A cross-sectional analysis was performed in the control group (n=1746). The other 3 groups watched short films: one group watched a film with scenes of nature (n=2650), another group watched a film on laughing people (n=2735), and the last group watched a film on physically painful events (n=2708). Immediately after the film viewing, participants were directed to the Pain Sensitivity Questionnaire to measure their pain sensitivity. The Pain Sensitivity Questionnaire score was stated as a mean per question on the numeric rating scale from 0-1. The cross-sectional study revealed no significant differences between men and women but showed male-female differences in the Pain Sensitivity Questionnaire when specific background factors were present. Watching a short film had a positive impact on the pain sensitivity of the respondents who had chronic pain, with a higher effect observed in female respondents. Conclusions: Scientists performing pain research need to account for factors that can influence the outcome of their study and be aware that these factors can be sex-dependent, and pain sensitivity should be analyzed accordingly. Even relatively small interventions such as watching a film can impact pain sensitivity, especially in respondents with current chronic pain. This effect can vary as well when different background factors are present. Our findings warrant further explorations of the possibilities that simple interventions bring for patients in personalized medicine. Trial Registration: Landelijk Trial Register NTR-new NL8182; https://onderzoekmetmensen.nl/en/trial/29537 UR - https://www.jmir.org/2024/1/e53926 UR - http://dx.doi.org/10.2196/53926 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/53926 ER - TY - JOUR AU - Lowe, Cabella AU - Sephton, Ruth AU - Marsh, William AU - Morrissey, Dylan PY - 2024/7/30 TI - Evaluation of a Musculoskeletal Digital Assessment Routing Tool (DART): Crossover Noninferiority Randomized Pilot Trial JO - JMIR Form Res SP - e56715 VL - 8 KW - mHealth KW - eHealth KW - digital health KW - digital technology KW - digital triage KW - musculoskeletal KW - triage KW - physiotherapy triage KW - validation KW - acceptability KW - physiotherapy KW - primary care KW - randomized controlled trial KW - usability KW - assess KW - assessment KW - triaging KW - referrals KW - crossover N2 - Background: Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on patients and increasing demand for health care use. Triage directing patients to appropriate level intervention improving health outcomes and efficiency has been prioritized. We developed a musculoskeletal digital assessment routing tool (DART) mobile health (mHealth) system, which requires evaluation prior to implementation. Such innovations are rarely rigorously tested in clinical trials?considered the gold standard for evaluating safety and efficacy. This pilot study is a precursor to a trial assessing DART performance with a physiotherapist-led triage assessment. Objective: The study aims to evaluate trial design, assess procedures, and collect exploratory data to establish the feasibility of delivering an adequately powered, definitive randomized trial, assessing DART safety and efficacy in an NHS primary care setting. Methods: A crossover, noninferiority pilot trial using an integrated knowledge translation approach within a National Health Service England primary care setting. Participants were patients seeking assessment for a musculoskeletal condition, completing a DART assessment and the history-taking element of a face-to-face physiotherapist-led triage in a randomized order. The primary outcome was agreement between DART and physiotherapist triage recommendation. Data allowed analysis of participant recruitment and retention, randomization, blinding, study burden, and potential barriers to intervention delivery. Participant satisfaction was measured using the System Usability Scale. Results: Over 8 weeks, 129 patients were invited to participate. Of these, 92% (119/129) proceeded to eligibility assessment, with 60% (78/129) meeting the inclusion criteria and being randomized into each intervention arm (39/39). There were no dropouts and data were analyzed for all 78 participants. Agreement between physiotherapist and DART across all participants and all primary triage outcomes was 41% (32/78; 95% CI 22-45), intraclass correlation coefficient 0.37 (95% CI 0.16-0.55), indicating that the reliability of DART was poor to moderate. Feedback from the clinical service team led to an adjusted analysis yielding of 78% (61/78; 95% CI 47-78) and an intraclass correlation coefficient of 0.57 (95% CI 0.40-0.70). Participant satisfaction was measured quantitively using amalgamated System Usability Scale scores (n=78; mean score 84.0; 90% CI +2.94 to ?2.94), equating to an ?excellent? system. There were no study incidents, and the trial burden was acceptable. Conclusions: Physiotherapist-DART agreement of 78%, with no adverse triage decisions and high patient satisfaction, was sufficient to conclude DART had the potential to improve the musculoskeletal pathway. Study validity was enhanced by the recruitment of real-world patients and using an integrated knowledge translation approach. Completion of a context-specific consensus process is recommended to provide definitive definitions of safety criteria, range of appropriateness, noninferiority margin, and sample size. This pilot demonstrated an adequately powered definitive trial is feasible, which would provide evidence of DART safety and efficacy, ultimately informing potential for DART implementation. Trial Registration: ClinicalTrials.gov NCT04904029; http://clinicaltrials.gov/ct2/show/NCT04904029 International Registered Report Identifier (IRRID): RR2-10.2196/31541 UR - https://formative.jmir.org/2024/1/e56715 UR - http://dx.doi.org/10.2196/56715 UR - http://www.ncbi.nlm.nih.gov/pubmed/39078682 ID - info:doi/10.2196/56715 ER - TY - JOUR AU - Little, L. Claire AU - Schultz, M. David AU - House, Thomas AU - Dixon, G. William AU - McBeth, John PY - 2024/7/19 TI - Identifying Weekly Trajectories of Pain Severity Using Daily Data From an mHealth Study: Cluster Analysis JO - JMIR Mhealth Uhealth SP - e48582 VL - 12 KW - mobile health KW - mHealth KW - pain KW - cluster KW - trajectory KW - k-medoids KW - transition KW - forecast KW - mobile phone N2 - Background: People with chronic pain experience variability in their trajectories of pain severity. Previous studies have explored pain trajectories by clustering sparse data; however, to understand daily pain variability, there is a need to identify clusters of weekly trajectories using daily pain data. Between-week variability can be explored by quantifying the week-to-week movement between these clusters. We propose that future work can use clusters of pain severity in a forecasting model for short-term (eg, daily fluctuations) and longer-term (eg, weekly patterns) variability. Specifically, future work can use clusters of weekly trajectories to predict between-cluster movement and within-cluster variability in pain severity. Objective: This study aims to understand clusters of common weekly patterns as a first stage in developing a pain-forecasting model. Methods: Data from a population-based mobile health study were used to compile weekly pain trajectories (n=21,919) that were then clustered using a k-medoids algorithm. Sensitivity analyses tested the impact of assumptions related to the ordinal and longitudinal structure of the data. The characteristics of people within clusters were examined, and a transition analysis was conducted to understand the movement of people between consecutive weekly clusters. Results: Four clusters were identified representing trajectories of no or low pain (1714/21,919, 7.82%), mild pain (8246/21,919, 37.62%), moderate pain (8376/21,919, 38.21%), and severe pain (3583/21,919, 16.35%). Sensitivity analyses confirmed the 4-cluster solution, and the resulting clusters were similar to those in the main analysis, with at least 85% of the trajectories belonging to the same cluster as in the main analysis. Male participants spent longer (participant mean 7.9, 95% bootstrap CI 6%-9.9%) in the no or low pain cluster than female participants (participant mean 6.5, 95% bootstrap CI 5.7%-7.3%). Younger people (aged 17-24 y) spent longer (participant mean 28.3, 95% bootstrap CI 19.3%-38.5%) in the severe pain cluster than older people (aged 65-86 y; participant mean 9.8, 95% bootstrap CI 7.7%-12.3%). People with fibromyalgia (participant mean 31.5, 95% bootstrap CI 28.5%-34.4%) and neuropathic pain (participant mean 31.1, 95% bootstrap CI 27.3%-34.9%) spent longer in the severe pain cluster than those with other conditions, and people with rheumatoid arthritis spent longer (participant mean 7.8, 95% bootstrap CI 6.1%-9.6%) in the no or low pain cluster than those with other conditions. There were 12,267 pairs of consecutive weeks that contributed to the transition analysis. The empirical percentage remaining in the same cluster across consecutive weeks was 65.96% (8091/12,267). When movement between clusters occurred, the highest percentage of movement was to an adjacent cluster. Conclusions: The clusters of pain severity identified in this study provide a parsimonious description of the weekly experiences of people with chronic pain. These clusters could be used for future study of between-cluster movement and within-cluster variability to develop accurate and stakeholder-informed pain-forecasting tools. UR - https://mhealth.jmir.org/2024/1/e48582 UR - http://dx.doi.org/10.2196/48582 UR - http://www.ncbi.nlm.nih.gov/pubmed/39028557 ID - info:doi/10.2196/48582 ER - TY - JOUR AU - Wu, Weizi AU - Graziano, Teresa AU - Salner, Andrew AU - Chen, Ming-Hui AU - Judge, P. Michelle AU - Cong, Xiaomei AU - Xu, Wanli PY - 2024/7/18 TI - Acceptability, Effectiveness, and Roles of mHealth Applications in Supporting Cancer Pain Self-Management: Integrative Review JO - JMIR Mhealth Uhealth SP - e53652 VL - 12 KW - cancer pain KW - self-management KW - mHealth applications KW - integrative review KW - cancer survivors N2 - Background:  Cancer pain remains highly prevalent and persistent throughout survivorship, and it is crucial to investigate the potential of leveraging the advanced features of mobile health (mHealth) apps to empower individuals to self-manage their pain. Objective:  This review aims to comprehensively understand the acceptability, users? experiences, and effectiveness of mHealth apps in supporting cancer pain self-management. Methods:  We conducted an integrative review following Souza and Whittemore and Knafl?s 6 review processes. Literature was searched in PubMed, Scopus, CINAHL Plus with Full Text, PsycINFO, and Embase, from 2013 to 2023. Keywords including ?cancer patients,? ?pain,? ?self-management,? ?mHealth applications,? and relevant synonyms were used in the search. The Johns Hopkins research evidence appraisal tool was used to evaluate the quality of eligible studies. A narrative synthesis was conducted to analyze the extracted data. Results:  A total of 20 studies were included, with the overall quality rated as high (n=15) to good (n=5). Using mHealth apps to monitor and manage pain was acceptable for most patients with cancer. The internal consistency of the mHealth in measuring pain was 0.96. The reported daily assessment or engagement rate ranged from 61.9% to 76.8%. All mHealth apps were designed for multimodal interventions. Participants generally had positive experiences using pain apps, rating them as enjoyable and user-friendly. In addition, 6 studies reported significant improvements in health outcomes, including enhancement in pain remission (severity and intensity), medication adherence, and a reduced frequency of breakthrough pain. The most frequently highlighted roles of mHealth apps included pain monitoring, tracking, reminders, education facilitation, and support coordination. Conclusions:  mHealth apps are effective and acceptable in supporting pain self-management. They offer a promising multi-model approach for patients to monitor, track, and manage their pain. These findings provide evidence-based insights for leveraging mHealth apps to support cancer pain self-management. More high-quality studies are needed to examine the effectiveness of digital technology?based interventions for cancer pain self-management and to identify the facilitators and barriers to their implementation in real-world practice. UR - https://mhealth.jmir.org/2024/1/e53652 UR - http://dx.doi.org/10.2196/53652 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/53652 ER - TY - JOUR AU - Park, Sunghee AU - Lee, Sohye AU - Howard, Sheri AU - Yi, Jeeseon PY - 2024/7/8 TI - Technology-Based Music Interventions to Reduce Anxiety and Pain Among Patients Undergoing Surgery or Procedures: Systematic Review of the Literature JO - JMIR Mhealth Uhealth SP - e48802 VL - 12 KW - technology KW - music intervention KW - anxiety KW - pain N2 - Background: Hospitalized patients undergoing surgery or procedures may experience negative symptoms. Music is a nonpharmacological complementary approach and is used as an intervention to reduce anxiety, stress, and pain in these patients. Recently, music has been used conveniently in clinical situations with technology devices, and the mode of providing music is an important factor in technology-based music interventions. However, many reviews have focused only on the effectiveness of music interventions. Objective: We aimed to review randomized controlled trials (RCTs) of technology-based music interventions for reducing anxiety and pain among patients undergoing surgery or procedures. We examined the clinical situation, devices used, delivery methods, and effectiveness of technology-based music interventions in primary articles. Methods: The search was performed in the following 5 electronic databases: PubMed, MEDLINE (OvidSP), CINAHL complete, PSYCINFO, and Embase. This systematic review focused on technology-based music interventions. The following articles were included: (1) RCTs, (2) studies using interactive technology (eg, smartphones, mHealth, tablets, applications, and virtual reality), (3) empirical studies reporting pain and anxiety outcomes, and (4) English articles published from 2018 to 2023 (as of January 18, 2023). The risk of bias was assessed using the Cochrane Risk of Bias tool version 2. Results: Among 292 studies identified, 21 met the inclusion criteria and were included. Of these studies, 9 reported that anxiety scores decreased after music interventions and 7 reported that pain could be decreased before, during, and after procedures. The methodology of the music intervention was important to the results on anxiety and pain in the clinical trials. More than 50% (13/21, 62%) of the studies included in this review allowed participants to select themes themselves. However, it was difficult to distinguish differences in effects depending on the device or software used for the music interventions. Conclusions: Technology-based music interventions could help reduce anxiety and pain among patients undergoing surgery or procedures. The findings of this review could help medical teams to choose a practical methodology for music interventions. Future studies should examine the effects of advanced technology-based music interventions using smart devices and software that promote interactions between medical staff and patients. UR - https://mhealth.jmir.org/2024/1/e48802 UR - http://dx.doi.org/10.2196/48802 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/48802 ER - TY - JOUR AU - Görges, Matthias AU - Sujan, Jonath AU - West, C. Nicholas AU - Sreepada, Syamala Rama AU - Wood, D. Michael AU - Payne, A. Beth AU - Shetty, Swati AU - Gelinas, P. Jean AU - Sutherland, M. Ainsley PY - 2024/7/2 TI - Postsurgical Pain Risk Stratification to Enhance Pain Management Workflow in Adult Patients: Design, Implementation, and Pilot Evaluation JO - JMIR Perioper Med SP - e54926 VL - 7 KW - patient-oriented research KW - patient-reported outcome measures KW - risk prediction KW - pain KW - individualized risk KW - surgery KW - anesthesia KW - opioid analgesia KW - short-term opioid use KW - care planning KW - digital health platforms N2 - Background: Exposure to opioids after surgery is the initial contact for some people who develop chronic opioid use disorder. Hence, effective postoperative pain management, with less reliance on opioids, is critical. The Perioperative Opioid Quality Improvement (POQI) program developed (1) a digital health platform leveraging patient-survey-reported risk factors and (2) a postsurgical pain risk stratification algorithm to personalize perioperative care by integrating several commercially available digital health solutions into a combined platform. Development was reduced in scope by the COVID-19 pandemic. Objective: This pilot study aims to assess the screening performance of the risk algorithm, quantify the use of the POQI platform, and evaluate clinicians? and patients? perceptions of its utility and benefit. Methods: A POQI platform prototype was implemented in a quality improvement initiative at a Canadian tertiary care center and evaluated from January to September 2022. After surgical booking, a preliminary risk stratification algorithm was applied to health history questionnaire responses. The estimated risk guided the patient assignment to a care pathway based on low or high risk for persistent pain and opioid use. Demographic, procedural, and medication administration data were extracted retrospectively from the electronic medical record. Postoperative inpatient opioid use of >90 morphine milligram equivalents per day was the outcome used to assess algorithm performance. Data were summarized and compared between the low- and high-risk groups. POQI use was assessed by completed surveys on postoperative days 7, 14, 30, 60, 90, and 120. Semistructured patient and clinician interviews provided qualitative feedback on the platform. Results: Overall, 276 eligible patients were admitted for colorectal procedures. The risk algorithm stratified 203 (73.6%) as the low-risk group and 73 (26.4%) as the high-risk group. Among the 214 (77.5%) patients with available data, high-risk patients were younger than low-risk patients (age: median 53, IQR 40-65 years, vs median 59, IQR 49-69 years, median difference five years, 95% CI 1-9; P=.02) and were more often female patients (45/73, 62% vs 80/203, 39.4%; odds ratio 2.5, 95% CI 1.4-4.5; P=.002). The risk stratification was reasonably specific (true negative rate=144/200, 72%) but not sensitive (true positive rate=10/31, 32%). Only 39.7% (85/214) patients completed any postoperative quality of recovery questionnaires (only 14, 6.5% patients beyond 60 days after surgery), and 22.9% (49/214) completed a postdischarge medication survey. Interviewed participants welcomed the initiative but noted usability issues and poor platform education. Conclusions: An initial POQI platform prototype was deployed operationally; the risk algorithm had reasonable specificity but poor sensitivity. There was a significant loss to follow-up in postdischarge survey completion. Clinicians and patients appreciated the potential impact of preemptively addressing opioid exposure but expressed shortcomings in the platform?s design and implementation. Iterative platform redesign with additional features and reevaluation are required before broader implementation. UR - https://periop.jmir.org/2024/1/e54926 UR - http://dx.doi.org/10.2196/54926 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/54926 ER - TY - JOUR AU - Gold, I. Jeffrey AU - Akbar, M. Krystal AU - Avila, Sandra AU - Ngo, H. Nhat AU - Klein, J. Margaret PY - 2024/7/1 TI - Exploring Relations Between Unique Patient Characteristics and Virtual Reality Immersion Level on Anxiety and Pain in Patients Undergoing Venipuncture: Secondary Analysis of a Randomized Control Trial JO - J Med Internet Res SP - e53196 VL - 26 KW - pediatrics KW - virtual reality KW - VR KW - immersion KW - anxiety KW - pain management KW - routine medical procedures KW - venipuncture KW - secondary data analysis KW - mediation KW - moderation KW - pain KW - acute pain KW - pediatric pain KW - anxiety sensitivity N2 - Background: Virtual reality (VR) is a well-researched digital intervention that has been used for managing acute pain and anxiety in pediatric patients undergoing various medical procedures. This study focuses on investigating the role of unique patient characteristics and VR immersion level on the effectiveness of VR for managing pediatric pain and anxiety during venipuncture. Objective: The purpose of this study is to determine how specific patient characteristics and level of immersion during a VR intervention impact anxiety and pain levels for pediatric patients undergoing venipuncture procedures. Methods: This study is a secondary data analysis of 2 combined, previously published randomized control trials on 252 pediatric patients aged 10-21 years observed at Children?s Hospital Los Angeles from April 12, 2017, to July 24, 2019. One randomized clinical trial was conducted in 3 clinical environments examining peripheral intravenous catheter placement (radiology and an infusion center) and blood draw (phlebotomy). Conditional process analysis was used to conduct moderation and mediation analyses to assess the impact of immersion level during the VR intervention. Results: Significant moderation was found between the level of immersion and anxiety sensitivity when predicting postprocedural anxiety (P=.01). Patients exhibiting the highest anxiety sensitivity within the standard of care yielded a 1.9 (95% CI 0.9-2.8; P<.001)-point elevation in postprocedural anxiety relative to individuals with high immersion levels. No other significant factors were found to mediate or moderate the effect of immersion on either postprocedural anxiety or pain. Conclusions: VR is most effective for patients with higher anxiety sensitivity who report feeling highly immersed. Age, location of the procedure, and gender of the patient were not found to significantly impact VR?s success in managing levels of postprocedural pain or anxiety, suggesting that immersive VR may be a beneficial intervention for a broad pediatric population. Trial Registration: ClinicalTrials.gov NCT04268901; https://clinicaltrials.gov/study/NCT04268901 UR - https://www.jmir.org/2024/1/e53196 UR - http://dx.doi.org/10.2196/53196 UR - http://www.ncbi.nlm.nih.gov/pubmed/38949862 ID - info:doi/10.2196/53196 ER - TY - JOUR AU - Porta, Xènia AU - Nieto, Rubén AU - Serrat, Mayte AU - Bourdin Kreitz, Pierre PY - 2024/6/18 TI - Perception of People Diagnosed With Fibromyalgia About Information and Communication Technologies for Chronic Pain Management: Cross-Sectional Survey Study JO - JMIR Form Res SP - e55751 VL - 8 KW - fibromyalgia KW - chronic pain KW - pain management KW - information and communication technologies KW - use KW - satisfaction N2 - Background: Chronic pain is prevalent in our society, with conditions such as fibromyalgia being notably widespread. The gold standard for aiding individuals dealing with chronic pain involves interdisciplinary approaches rooted in a biopsychosocial perspective. Regrettably, access to such care is difficult for most of the people in need. Information and communication technologies (ICTs) have been used as a way of overcoming access barriers (among other advantages). Objective: This study addressed the little explored area of how individuals with fibromyalgia use and perceive different types of ICTs for pain management. Methods: A cross-sectional study was conducted using an online survey. This survey was created to assess the use of different ICT tools for pain management, satisfaction with the tools used, and perceived advantages and disadvantages. In addition, data collection encompassed sociodemographic variables and pain-related variables, pain intensity, the impact of pain on daily life activities, and fear of movement/injury beliefs. In total, 265 individuals diagnosed with fibromyalgia completed the survey. Results: Only 2 (0.75%) participants reported not having used any ICT tool for pain management. Among those who used ICT tools, an average of 10.94 (SD 4.48) of 14 different tools were used, with the most used options being instant messaging apps, websites dedicated to managing fibromyalgia, phone calls with health professionals, and online multimedia resources. Satisfaction rates were relatively modest (mean 2.09, SD 0.38) on a scale from 0 to 5, with instant messaging apps, phone calls with health professionals, fibromyalgia management websites, and online multimedia resources being the ones with higher satisfaction. Participants appreciated the ability to receive treatment from home, access to specialized treatment, and using ICTs as a supplement to in-person interventions. However, they also highlighted drawbacks, such as a lack of close contact with health professionals, difficulty expressing emotions, and a lack of knowledge or resources to use ICTs. The use of ICTs was influenced by age and educational background. Additionally, there was a negative correlation between satisfaction with ICT tools and fear of movement/injury. Conclusions: People with fibromyalgia are prone to using ICTs for pain management, especially those tools that allow them to be in contact with health professionals and have access to online resources. However, there is still a need to improve ICT tools since satisfaction ratings are modest. Moreover, strategies aimed at older people, those with lower levels of education, and those with higher levels of fear of movement/injury can be useful to potentiate the use of ICTs among them. UR - https://formative.jmir.org/2024/1/e55751 UR - http://dx.doi.org/10.2196/55751 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/55751 ER - TY - JOUR AU - Delage, Noémie AU - Cantagrel, Nathalie AU - Soriot-Thomas, Sandrine AU - Frost, Marie AU - Deleens, Rodrigue AU - Ginies, Patrick AU - Eschalier, Alain AU - Corteval, Alice AU - Laveyssière, Alicia AU - Phalip, Jules AU - Bertin, Célian AU - Pereira, Bruno AU - Chenaf, Chouki AU - Doreau, Bastien AU - Authier, Nicolas AU - AU - Kerckhove, Nicolas PY - 2024/6/12 TI - Mobile Health App and Web Platform (eDOL) for Medical Follow-Up of Patients With Chronic Pain: Cohort Study Involving the French eDOL National Cohort After 1 Year JO - JMIR Mhealth Uhealth SP - e54579 VL - 12 KW - mHealth KW - mobile health KW - eHealth KW - self-monitoring KW - chronic pain KW - observational study N2 - Background: Chronic pain affects approximately 30% of the general population, severely degrades quality of life and professional life, and leads to additional health care costs. Moreover, the medical follow-up of patients with chronic pain remains complex and provides only fragmentary data on painful daily experiences. This situation makes the management of patients with chronic pain less than optimal and may partly explain the lack of effectiveness of current therapies. Real-life monitoring of subjective and objective markers of chronic pain using mobile health (mHealth) programs could better characterize patients, chronic pain, pain medications, and daily impact to help medical management. Objective: This cohort study aimed to assess the ability of our mHealth tool (eDOL) to collect extensive real-life medical data from chronic pain patients after 1 year of use. The data collected in this way would provide new epidemiological and pathophysiological data on chronic pain. Methods: A French national cohort of patients with chronic pain treated at 18 pain clinics has been established and followed up using mHealth tools. This cohort makes it possible to collect the determinants and repercussions of chronic pain and their evolutions in a real-life context, taking into account all environmental events likely to influence chronic pain. The patients were asked to complete several questionnaires, body schemes, and weekly meters, and were able to interact with a chatbot and use educational modules on chronic pain. Physicians could monitor their patients? progress in real time via an online platform. Results: The cohort study included 1427 patients and analyzed 1178 patients. The eDOL tool was able to collect various sociodemographic data; specific data for characterizing pain disorders, including body scheme; data on comorbidities related to chronic pain and its psychological and overall impact on patients? quality of life; data on drug and nondrug therapeutics and their benefit-to-risk ratio; and medical or treatment history. Among the patients completing weekly meters, 49.4% (497/1007) continued to complete them after 3 months of follow-up, and the proportion stabilized at 39.3% (108/275) after 12 months of follow-up. Overall, despite a fairly high attrition rate over the follow-up period, the eDOL tool collected extensive data. This amount of data will increase over time and provide a significant volume of health data of interest for future research involving the epidemiology, care pathways, trajectories, medical management, sociodemographic characteristics, and other aspects of patients with chronic pain. Conclusions: This work demonstrates that the mHealth tool eDOL is able to generate a considerable volume of data concerning the determinants and repercussions of chronic pain and their evolutions in a real-life context. The eDOL tool can incorporate numerous parameters to ensure the detailed characterization of patients with chronic pain for future research and pain management. Trial Registration: ClinicalTrials.gov NCT04880096; https://clinicaltrials.gov/ct2/show/NCT04880096 UR - https://mhealth.jmir.org/2024/1/e54579 UR - http://dx.doi.org/10.2196/54579 UR - http://www.ncbi.nlm.nih.gov/pubmed/38865173 ID - info:doi/10.2196/54579 ER - TY - JOUR AU - Klein, R. Morgan AU - Darnall, D. Beth AU - You, S. Dokyoung PY - 2024/6/6 TI - Feasibility of Web-Based Single-Session Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Protocol for a Single-Arm Trial JO - JMIR Res Protoc SP - e53784 VL - 13 KW - chronic pain KW - opioid use disorder KW - methadone KW - buprenorphine KW - behavioral medicine KW - telehealth KW - psychology N2 - Background: Chronic pain affects tens of millions of US adults and continues to rise in prevalence. Nonpharmacologic behavioral pain treatments are greatly needed and yet are often inaccessible, particularly in settings where medication prescribing is prioritized. Objective: This study aims to test the feasibility of a live-instructor, web-based 1-session pain relief skills class in an underserved and potentially at-risk population: people with chronic pain prescribed methadone or buprenorphine either solely for pain or for comorbid opioid use disorder (OUD). Methods: This is a national, prospective, single-arm, uncontrolled feasibility trial. The trial is untethered from medical care; to enhance participants? willingness to join the study, no medical records or drug-monitoring records are accessed. At least 45 participants will be recruited from outpatient pain clinics and from an existing research database of individuals who have chronic pain and are taking methadone or buprenorphine. Patient-reported measures will be collected at 6 time points (baseline, immediately post treatment, 2 weeks, and months 1-3) via a web-based platform, paper, or phone formats to include individuals with limited internet or computer access and low literacy skills. At baseline, participants complete demographic questions and 13 study measures (Treatment Expectations, Body Pain Map, Medication Use, Pain Catastrophizing Scale [PCS], Patient-Reported Outcomes Measurement Information System [PROMIS] Measures, and Opioid Craving Scale). Immediately post treatment, a treatment satisfaction and acceptability measure is administered on a 0 (very dissatisfied) to 10 (completely satisfied) scale, with 3 of these items being the primary outcome (perceived usefulness, participant satisfaction, and likelihood of using the skills). At each remaining time point, the participants complete all study measures minus treatment expectations and satisfaction. Participants who do not have current OUD will be assessed for historical OUD, with presence of OUD (yes or no), and history of OUD (yes or no) reported separately. Feasibility threshold is set as an overall group treatment satisfaction rating of 8 of 10. In-depth qualitative interviews will be conducted with about 10 participants to obtain additional data on patient perceptions, satisfactions, needs, and wants. To assess preliminary efficacy, we will examine changes in pain catastrophizing, pain intensity, pain bothersomeness, sleep disturbance, pain interference, depression, anxiety, physical function, global impression of change, and opioid craving at 1 month post treatment. Results: This project opened to enrollment in September 2021 and completed the recruitment in October 2023. The data collection was completed in February 2024. Results are expected to be published in late 2024. Conclusions: Results from this trial will inform the feasibility and preliminary efficacy of Empowered Relief in this population and will inform the design of a future randomized controlled trial testing web-based Empowered Relief in chronic pain and comorbid OUD. Trial Registration: ClinicalTrials.gov NCT05057988; https://clinicaltrials.gov/study/NCT05057988 International Registered Report Identifier (IRRID): DERR1-10.2196/53784 UR - https://www.researchprotocols.org/2024/1/e53784 UR - http://dx.doi.org/10.2196/53784 UR - http://www.ncbi.nlm.nih.gov/pubmed/38843513 ID - info:doi/10.2196/53784 ER - TY - JOUR AU - Elser, Alexander AU - Lange, Marina AU - Kopkow, Christian AU - Schäfer, Georg Axel PY - 2024/5/15 TI - Barriers and Facilitators to the Implementation of Virtual Reality Interventions for People With Chronic Pain: Scoping Review JO - JMIR XR Spatial Comput SP - e53129 VL - 1 KW - virtual reality KW - VR KW - chronic pain KW - implementation science KW - scoping review KW - barriers KW - facilitators N2 - Background: Chronic pain is a growing health problem worldwide with a significant impact on individuals and societies. In regard to treatment, there is a gap between guideline recommendations and common practice in health care, especially concerning cognitive and psychological interventions. Virtual reality (VR) may provide a way to improve this situation. A growing body of evidence indicates that VR therapy has positive effects on pain and physical function. However, there is limited knowledge about barriers and facilitators to the implementation of VR interventions for people with chronic pain in health care settings. Objective: The aim of this study was to identify and analyze the barriers and facilitators involved in implementing VR interventions for people with chronic pain. Methods: We conducted a scoping review of the German and English literature using the MEDLINE, Cochrane Central Register of Controlled Trials, CINAHL, PEDro, LILACS, and Web of Science (inception to November 2023) databases, including quantitative, qualitative, and mixed methods studies reporting barriers and facilitators to the implementation of VR interventions for people with chronic pain, as reported by patients or health care professionals. Two reviewers systematically screened the abstracts and full texts of retrieved articles according to the inclusion criteria. All mentioned barriers and facilitators were extracted and categorized according to the Theoretical Domains Framework (TDF). Results: The database search resulted in 1864 records after removal of duplicates. From the 14 included studies, 30 barriers and 33 facilitators from the patient perspective and 2 facilitators from the health care professional perspective were extracted. Barriers reported by people with chronic pain were most frequently assigned to the TDF domains environmental context (60%) and skills (16.7%). Most facilitators were found in three domains for both the patients and health care professionals: beliefs about consequences (30.3%), emotions (18.2%), and environmental context (18.2%). Conclusions: The findings of this review can inform the development of strategies for future implementations of VR interventions for people with chronic pain. Additionally, further research should address knowledge gaps about the perspective of health care professionals regarding the implementation of VR interventions for people with chronic pain. UR - https://xr.jmir.org/2024/1/e53129 UR - http://dx.doi.org/10.2196/53129 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/53129 ER - TY - JOUR AU - Granviken, Fredrik AU - Vasseljen, Ottar AU - Bach, Kerstin AU - Jaiswal, Amar AU - Meisingset, Ingebrigt PY - 2024/5/10 TI - Decision Support for Managing Common Musculoskeletal Pain Disorders: Development of a Case-Based Reasoning Application JO - JMIR Form Res SP - e44805 VL - 8 KW - case-based reasoning KW - musculoskeletal pain KW - physiotherapy KW - decision support KW - primary care KW - artificial intelligence N2 - Background: Common interventions for musculoskeletal pain disorders either lack evidence to support their use or have small to modest or short-term effects. Given the heterogeneity of patients with musculoskeletal pain disorders, treatment guidelines and systematic reviews have limited transferability to clinical practice. A problem-solving method in artificial intelligence, case-based reasoning (CBR), where new problems are solved based on experiences from past similar problems, might offer guidance in such situations. Objective: This study aims to use CBR to build a decision support system for patients with musculoskeletal pain disorders seeking physiotherapy care. This study describes the development of the CBR system SupportPrim PT and demonstrates its ability to identify similar patients. Methods: Data from physiotherapy patients in primary care in Norway were collected to build a case base for SupportPrim PT. We used the local-global principle in CBR to identify similar patients. The global similarity measures are attributes used to identify similar patients and consisted of prognostic attributes. They were weighted in terms of prognostic importance and choice of treatment, where the weighting represents the relevance of the different attributes. For the local similarity measures, the degree of similarity within each attribute was based on minimal clinically important differences and expert knowledge. The SupportPrim PT?s ability to identify similar patients was assessed by comparing the similarity scores of all patients in the case base with the scores on an established screening tool (the short form Örebro Musculoskeletal Pain Screening Questionnaire [ÖMSPQ]) and an outcome measure (the Musculoskeletal Health Questionnaire [MSK-HQ]) used in musculoskeletal pain. We also assessed the same in a more extensive case base. Results: The original case base contained 105 patients with musculoskeletal pain (mean age 46, SD 15 years; 77/105, 73.3% women). The SupportPrim PT consisted of 29 weighted attributes with local similarities. When comparing the similarity scores for all patients in the case base, one at a time, with the ÖMSPQ and MSK-HQ, the most similar patients had a mean absolute difference from the query patient of 9.3 (95% CI 8.0-10.6) points on the ÖMSPQ and a mean absolute difference of 5.6 (95% CI 4.6-6.6) points on the MSK-HQ. For both ÖMSPQ and MSK-HQ, the absolute score difference increased as the rank of most similar patients decreased. Patients retrieved from a more extensive case base (N=486) had a higher mean similarity score and were slightly more similar to the query patients in ÖMSPQ and MSK-HQ compared with the original smaller case base. Conclusions: This study describes the development of a CBR system, SupportPrim PT, for musculoskeletal pain in primary care. The SupportPrim PT identified similar patients according to an established screening tool and an outcome measure for patients with musculoskeletal pain. UR - https://formative.jmir.org/2024/1/e44805 UR - http://dx.doi.org/10.2196/44805 UR - http://www.ncbi.nlm.nih.gov/pubmed/38728686 ID - info:doi/10.2196/44805 ER - TY - JOUR AU - Mittal, Ajay AU - Wakim, Jonathan AU - Huq, Suhaiba AU - Wynn, Tung PY - 2024/5/9 TI - Effectiveness of Virtual Reality in Reducing Perceived Pain and Anxiety Among Patients Within a Hospital System: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e52649 VL - 13 KW - virtual reality KW - digital health KW - feasibility KW - acceptability KW - pain KW - anxiety KW - hospital KW - hospitalization KW - in-patient KW - observational study KW - pharmacologic pain management KW - pain management KW - topical anesthetic creams KW - topical cream N2 - Background: Within hospital systems, diverse subsets of patients are subject to minimally invasive procedures that provide therapeutic relief and necessary health data that are often perceived as anxiogenic or painful. These feelings are particularly relevant to patients experiencing procedures where they are conscious and not sedated or placed under general anesthesia that renders them incapacitated. Pharmacologic pain management and topical anesthetic creams are used to manage these feelings; however, distraction-based methods can provide nonpharmacologic means to modify the painful experience and discomfort often associated with these procedures. Recent studies support distraction as a useful method for reducing anxiety and pain and as a result, improving patient experience. Virtual reality (VR) is an emerging technology that provides an immersive user experience and can operate through a distraction-based method to reduce the negative or painful experience often related to procedures where the patient is conscious. Given the possible short-term and long-term outcomes of poorly managed pain and enduring among patients, health care professionals are challenged to improve patient well-being during medically essential procedures. Objective: The purpose of this pilot project is to assess the efficacy of using VR as a distraction-based intervention for anxiety or pain management compared to other nonpharmacologic interventions in a variety of hospital settings, specifically in patients undergoing lumbar puncture procedures and bone marrow biopsies at the oncology ward, patients receiving nerve block for a broken bone at an anesthesia or surgical center, patients undergoing a cleaning at a dental clinic, patients conscious during an ablation procedure at a cardiology clinic, and patients awake during a kidney biopsy at a nephrology clinic. This will provide the framework for additional studies in other health care settings. Methods: In a single visit, patients eligible for the study will complete brief preprocedural and postprocedural questionnaires about their perceived fear, anxiety, and pain levels. During the procedure, research assistants will place a VR headset on the patient and the patient will undergo a VR experience to distract from any pain felt from the procedure. Participants? vitals, including blood pressure, heart rate, and rate of respiration, will also be recorded before, during, and after the procedure. Results: The study is already underway, and results support a decrease in perceived pain by 1.00 and a decrease in perceived anxiety by 0.3 compared to the control group (on a 10-point Likert scale). Among the VR intervention group, the average rating for comfort was 4.35 out of 5. Conclusions: This study will provide greater insight into how patients? perception of anxiety and pain could potentially be altered. Furthermore, metrics related to the operational efficiency of providing a VR intervention compared to a control will provide insight into the feasibility and integration of such technologies in routine practice. International Registered Report Identifier (IRRID): DERR1-10.2196/52649 UR - https://www.researchprotocols.org/2024/1/e52649 UR - http://dx.doi.org/10.2196/52649 UR - http://www.ncbi.nlm.nih.gov/pubmed/38722681 ID - info:doi/10.2196/52649 ER - TY - JOUR AU - Marier-Deschenes, Pascale AU - Pinard, Marie Anne AU - Jalbert, Laura AU - LeBlanc, Annie PY - 2024/5/3 TI - Assessing the Feasibility and Preliminary Effects of a Web-Based Self-Management Program for Chronic Noncancer Pain: Mixed Methods Study JO - JMIR Hum Factors SP - e50747 VL - 11 KW - persistent pain KW - eHealth KW - self-paced intervention KW - web-based program KW - evidence based KW - web based KW - self-management KW - pain KW - chronic pain KW - mixed methods study KW - pain treatment KW - pain education N2 - Background: In Canada, adults with chronic noncancer pain face a persistent insufficiency of publicly funded resources, with the gold standard multidisciplinary pain treatment facilities unable to meet the high clinical demand. Web-based self-management programs cost-effectively increase access to pain management and can improve several aspects of physical and emotional functioning. Aiming to meet the demand for accessible, fully automated resources for individuals with chronic noncancer pain, we developed a French web- and evidence-based self-management program, Agir pour moi (APM). This program includes pain education and strategies to reduce stress, practice mindfulness, apply pacing, engage in physical activity, identify and manage thinking traps, sleep better, adapt diet, and sustain behavior change. Objective: This study aims to assess the APM self-management program?s feasibility, acceptability, and preliminary effects in adults awaiting specialized services from a center of expertise in chronic pain management. Methods: We conducted a mixed methods study with an explanatory sequential design, including a web-based 1-arm trial and qualitative semistructured interviews. We present the results from both phases through integrative tables called joint displays. Results: Response rates were 70% (44/63) at postintervention and 56% (35/63) at 3-month follow-up among the 63 consenting participants who provided self-assessed information at baseline. In total, 46% (29/63) of the participants completed the program. We interviewed 24% (15/63) of the participants. The interview?s first theme revolved around the overall acceptance, user-friendliness, and engaging nature of the program. The second theme emphasized the differentiation between microlevel and macrolevel engagements. The third theme delved into the diverse effects observed, potentially influenced by the macrolevel engagements. Participants highlighted the features that impacted their self-efficacy and the adoption of self-management strategies. We observed indications of improvement in self-efficacy, pain intensity, pain interference, depression, and catastrophizing. Interviewees described these and various other effects as potentially influenced by macrolevel engagement through behavioral change. Conclusions: These ?ndings provided preliminary evidence that the APM self-management program and research methods are feasible. However, some participants expressed the need for at least phone reminders and minimal support from a professional available to answer questions over the first few weeks of the program to engage. Recruitment strategies of a future randomized controlled trial should focus on attracting a broader representation of individuals with chronic pain in terms of gender and ethnicity. Trial Registration: ClinicalTrials.gov NCT05319652; https://clinicaltrials.gov/study/NCT05319652 UR - https://humanfactors.jmir.org/2024/1/e50747 UR - http://dx.doi.org/10.2196/50747 UR - http://www.ncbi.nlm.nih.gov/pubmed/38701440 ID - info:doi/10.2196/50747 ER - TY - JOUR AU - Weiß, Martin AU - Gründahl, Marthe AU - Jachnik, Annalena AU - Lampe, Caya Emilia AU - Malik, Ishitaa AU - Rittner, Lydia Heike AU - Sommer, Claudia AU - Hein, Grit PY - 2024/4/30 TI - The Effect of Everyday-Life Social Contact on Pain JO - J Med Internet Res SP - e53830 VL - 26 KW - social contact KW - pain KW - ecological momentary assessment UR - https://www.jmir.org/2024/1/e53830 UR - http://dx.doi.org/10.2196/53830 UR - http://www.ncbi.nlm.nih.gov/pubmed/38687594 ID - info:doi/10.2196/53830 ER - TY - JOUR AU - Guo, Qifan AU - Zhang, Liming AU - Han, Lianyi Leo AU - Gui, Chenfan AU - Chen, Guanghui AU - Ling, Chunyan AU - Wang, Wei AU - Gao, Qiang PY - 2024/4/24 TI - Effects of Virtual Reality Therapy Combined With Conventional Rehabilitation on Pain, Kinematic Function, and Disability in Patients With Chronic Neck Pain: Randomized Controlled Trial JO - JMIR Serious Games SP - e42829 VL - 12 KW - virtual reality KW - neck pain KW - disability KW - kinematic function KW - rehabilitation KW - physiotherapy KW - neck KW - pain KW - chronic KW - therapy KW - kinematic KW - efficacy KW - patient KW - effect N2 - Background: Neck pain is a common condition that leads to neck motor dysfunction and subsequent disability, with a significant global health care burden. As a newly emerging tool, virtual reality (VR) technology has been employed to address pain and reduce disability among patients with neck pain. However, there is still a lack of high-quality studies evaluating the efficacy of VR therapy combined with conventional rehabilitation for patients with chronic neck pain, particularly in terms of kinematic function. Objective: This study aims to investigate the effect of VR therapy combined with conventional rehabilitation on pain, kinematic function, and disability in patients with chronic neck pain. Methods: We conducted an assessor-blinded, allocation-concealed randomized controlled trial. Sixty-four participants experiencing chronic neck pain were randomly allocated into the experimental group that underwent VR rehabilitation plus conventional rehabilitation or the control group receiving the same amount of conventional rehabilitation alone for 10 sessions over 4 weeks. Pain intensity, disability, kinematic function (cervical range of motion, proprioception, and mean and peak velocity), degree of satisfaction, and relief of symptoms were evaluated at 3 timepoints (baseline, postintervention, and at 3 months follow-up). A 2*3 mixed repeated measures analysis of variance was utilized for analyzing the difference across indicators, with a significant difference level of .05. Results: Both groups demonstrated significant improvements in pain, disability, and kinematic functions (P<.05) at postintervention and at 3-month follow-up. The experimental group showed superior therapeutic outcomes compared to the control group in pain reduction (mean difference from the baseline: 5.50 vs 1.81 at posttreatment; 5.21 vs 1.91 at the 3-month follow-up, respectively; P<.001), disability improvement (mean difference from baseline: 3.04 vs 0.50 at posttreatment; 3.20 vs 0.85 at the 3-month follow-up, respectively; P<.001), and enhanced kinematic functions (P<.05). Moreover, participants in the experimental group reported better satisfaction and relief of symptoms than the control group (P<.05), with better initiative for exercising during the follow-up period. However, there was no between-group difference of improvement in proprioception. No adverse events were reported or observed in our research. Conclusions: The findings of our study support the efficacy of combining VR therapy with conventional rehabilitation in alleviating pain, enhancing kinematic function, and reducing disability of patients with chronic neck pain. Future research should focus on refining the therapeutic protocols and dosages for VR therapy as well as on optimizing its application in clinical settings for improved convenience and effectiveness. Trial Registration: Chinese Clinical Trial Registry ChiCTR2000040132; http://www.chictr.org.cn/showproj.aspx?proj=64346 UR - https://games.jmir.org/2024/1/e42829 UR - http://dx.doi.org/10.2196/42829 UR - http://www.ncbi.nlm.nih.gov/pubmed/38656775 ID - info:doi/10.2196/42829 ER - TY - JOUR AU - Huo, Jian AU - Yu, Yan AU - Lin, Wei AU - Hu, Anmin AU - Wu, Chaoran PY - 2024/4/12 TI - Application of AI in Multilevel Pain Assessment Using Facial Images: Systematic Review and Meta-Analysis JO - J Med Internet Res SP - e51250 VL - 26 KW - computer vision KW - facial image KW - monitoring KW - multilevel pain assessment KW - pain KW - postoperative KW - status N2 - Background: The continuous monitoring and recording of patients? pain status is a major problem in current research on postoperative pain management. In the large number of original or review articles focusing on different approaches for pain assessment, many researchers have investigated how computer vision (CV) can help by capturing facial expressions. However, there is a lack of proper comparison of results between studies to identify current research gaps. Objective: The purpose of this systematic review and meta-analysis was to investigate the diagnostic performance of artificial intelligence models for multilevel pain assessment from facial images. Methods: The PubMed, Embase, IEEE, Web of Science, and Cochrane Library databases were searched for related publications before September 30, 2023. Studies that used facial images alone to estimate multiple pain values were included in the systematic review. A study quality assessment was conducted using the Quality Assessment of Diagnostic Accuracy Studies, 2nd edition tool. The performance of these studies was assessed by metrics including sensitivity, specificity, log diagnostic odds ratio (LDOR), and area under the curve (AUC). The intermodal variability was assessed and presented by forest plots. Results: A total of 45 reports were included in the systematic review. The reported test accuracies ranged from 0.27-0.99, and the other metrics, including the mean standard error (MSE), mean absolute error (MAE), intraclass correlation coefficient (ICC), and Pearson correlation coefficient (PCC), ranged from 0.31-4.61, 0.24-2.8, 0.19-0.83, and 0.48-0.92, respectively. In total, 6 studies were included in the meta-analysis. Their combined sensitivity was 98% (95% CI 96%-99%), specificity was 98% (95% CI 97%-99%), LDOR was 7.99 (95% CI 6.73-9.31), and AUC was 0.99 (95% CI 0.99-1). The subgroup analysis showed that the diagnostic performance was acceptable, although imbalanced data were still emphasized as a major problem. All studies had at least one domain with a high risk of bias, and for 20% (9/45) of studies, there were no applicability concerns. Conclusions: This review summarizes recent evidence in automatic multilevel pain estimation from facial expressions and compared the test accuracy of results in a meta-analysis. Promising performance for pain estimation from facial images was established by current CV algorithms. Weaknesses in current studies were also identified, suggesting that larger databases and metrics evaluating multiclass classification performance could improve future studies. Trial Registration: PROSPERO CRD42023418181; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=418181 UR - https://www.jmir.org/2024/1/e51250 UR - http://dx.doi.org/10.2196/51250 UR - http://www.ncbi.nlm.nih.gov/pubmed/38607660 ID - info:doi/10.2196/51250 ER - TY - JOUR AU - MacLean, Ross R. AU - Ankawi, Brett AU - Driscoll, A. Mary AU - Gordon, A. Melissa AU - Frankforter, L. Tami AU - Nich, Charla AU - Szollosy, K. Sara AU - Loya, M. Jennifer AU - Brito, Larissa AU - Ribeiro, P. Margaridha I. AU - Edmond, N. Sara AU - Becker, C. William AU - Martino, Steve AU - Sofuoglu, Mehmet AU - Heapy, A. Alicia PY - 2024/3/20 TI - Efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT) in Individuals With Chronic Pain and Opioid Use Disorder: Protocol for a Randomized Clinical Trial of a Digital Cognitive Behavioral Treatment JO - JMIR Res Protoc SP - e54342 VL - 13 KW - chronic pain KW - digital treatment KW - medications for opioid use disorder KW - methadone KW - opioid use disorder N2 - Background: Chronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; eg, buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to their increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high-quality, clinician-delivered, empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD have the potential for wider implementation to fill this gap. Objective: This study aims to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback, compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD. Methods: Adult participants (n=160) receiving MOUD and reporting bothersome or high-impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut (United States) and randomized 1:1 to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant-reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected through digital surveys. Outcomes will be assessed at 3, 6, and 9 months post randomization. The primary outcome is MOUD retention at 3 months post randomization (ie, post treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semistructured qualitative interviews with study participants (n=34) randomized to IMPACT (completers and noncompleters) will be conducted to evaluate the usability and quality of the program and its outcomes. Results: The study has received institutional review board approval and began recruitment at 1 site in July 2022. Recruitment at a second site started in January 2023, with a third and final site anticipated to begin recruitment in January 2024. Data collection is expected to continue through June 2025. Conclusions: Establishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD, which reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates or modifications to improve engagement and efficacy. Trial Registration: ClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576 International Registered Report Identifier (IRRID): DERR1-10.2196/54342 UR - https://www.researchprotocols.org/2024/1/e54342 UR - http://dx.doi.org/10.2196/54342 UR - http://www.ncbi.nlm.nih.gov/pubmed/38506917 ID - info:doi/10.2196/54342 ER - TY - JOUR AU - Starkweather, R. Angela AU - Xu, Wanli AU - Gnall, E. Katherine AU - Emrich, Mariel AU - Garnsey, L. Camille AU - Magin, E. Zachary AU - Wu, Weizi AU - Fetta, Joseph AU - Groessl, J. Erik AU - Park, Crystal PY - 2024/3/14 TI - Testing Biological and Psychological Pathways of Emotion Regulation as a Primary Mechanism of Action in Yoga Interventions for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e56016 VL - 13 KW - chronic low back pain KW - clinical trial KW - emotion regulation KW - mind-body interventions KW - pain sensitivity KW - yoga N2 - Background: Interventions that promote adaptive emotion regulation (ER) skills reduce pain in patients with chronic pain; however, whether the effects of yoga practice on chronic low back pain (CLBP) are due to improvements in ER remains to be examined. Objective: This study will test whether the effects of yoga on CLBP (improved pain severity and interference) are mediated by improved ER, the extent to which effects are related to specific aspects of ER, and the role of pain sensitization as a mediator or moderator of effects. In this study, pain sensitization will be assessed by quantitative sensory testing and gene expression profiles to examine whether pain sensitization moderates yoga?s effects on pain or whether yoga and ER abilities reduce pain sensitization, leading to decreased pain severity and interference. Methods: For this 2-arm parallel group blinded randomized controlled trial, we will enroll 204 adults with CLBP who will be randomized to receive the yoga (n=102) or a control stretching and strengthening (n=102) intervention, which are delivered via web-based synchronous biweekly 75-minute sessions over 12 weeks. Participants are encouraged to practice postures or exercises for 25 minutes on other days using accessible prerecorded practice videos that are sent to participants digitally. Participants will be assessed at 5 time points: baseline, midintervention (6 weeks), postintervention (12 weeks), and 3- and 6-month follow-ups. Assessments of ER, pain severity and interference, pain sensitivity including somatosensory and gene expression profiles, and physical strength and flexibility will be conducted at each visit. The fidelity of the interventions is assessed using a manualized checklist to evaluate recorded group sessions to ensure consistent instructor delivery. Results: The primary outcome will be the mean change in pain severity as measured by the Brief Pain Inventory-Short Form at 12 weeks. The primary mechanism of action is ER measured by change in the Difficulties in Emotion Regulation Scale total score. Secondary outcomes include pain sensitivity, physical strength and flexibility, pain interference, and quality of life. A mediation path analysis and series of moderated mediation path analyses will be conducted to test the study hypotheses. As of January 2024, we have enrolled 138 participants. We expect the study to be completed by May 2025. Conclusions: The study will provide important data for evaluating whether improvements in ER are responsible for reduced pain perception and pain sensitivity as well as increased quality of life in the context of chronic pain. The study findings have important implications for determining the mechanism of action for yoga and possibly other mind-body interventions as nonpharmacological therapies for pain management. The results of the study will inform the content, delivery, and measures for intervention trials involving yoga as a modality for relieving pain and improving function. Trial Registration: ClinicalTrials.gov NCT04678297; https://clinicaltrials.gov/study/NCT04678297 International Registered Report Identifier (IRRID): DERR1-10.2196/56016 UR - https://www.researchprotocols.org/2024/1/e56016 UR - http://dx.doi.org/10.2196/56016 UR - http://www.ncbi.nlm.nih.gov/pubmed/38483469 ID - info:doi/10.2196/56016 ER - TY - JOUR AU - Main, Ashleigh AU - McCartney, Haruno AU - Ibrar, Maryam AU - Rai, Kaur Harleen AU - Muirhead, Fiona AU - Mavroeidi, Alexandra AU - Maguire, Roma PY - 2024/3/7 TI - Patients? Experiences of Digital Health Interventions for the Self-Management of Chronic Pain: Protocol for a Systematic Review and Thematic Synthesis JO - JMIR Res Protoc SP - e52469 VL - 13 KW - chronic pain KW - digital health KW - digital tool KW - digital health intervention KW - mHealth KW - eHealth KW - pain-management KW - person-centered KW - experience KW - protocol KW - patients' experiences KW - patient experiences KW - self-management KW - systematic review KW - thematic synthesis KW - protocol. N2 - Background: Chronic pain is a highly prevalent condition that requires multidisciplinary treatment. However, in the United Kingdom, access to specialist pain clinics where patients can receive medical multidisciplinary treatment is limited, and provision varies between health boards. As such, self-management of chronic pain using digital tools has been gaining traction recently, but evidence of its effectiveness from clinical-based trials focuses mainly on quantitative outcomes. Objective: This systematic review aims to identify, appraise, and synthesize qualitative evidence on patients? experiences with digital health interventions (DHIs) for the management of chronic pain. Methods: This systematic review will consider qualitative and mixed methods studies that explore the experience of patients (aged 18 years and older) with chronic pain engaging in DHIs to manage their pain. MEDLINE Ovid, PubMed, Embase, CINAHL, PsycINFO, and Scopus databases will be searched for published studies. The systematic review will be conducted in accordance with the ENTREQ (Enhancing Transparency in Reporting the Synthesis of Qualitative Research) guidelines. Following the 3-step thematic synthesis methodology of Thomas and Harden, titles and abstracts will be screened by 2 independent reviewers (AM and HM), and a third reviewer (MI or FM) will resolve any conflict that arises before the full-text screening. The Critical Appraisal Skills Programme checklist tool will be used to critically appraise the included studies. The extracted data will be imported to NVivo (QSR International), where thematic synthesis will be used to derive analytical themes from the included studies. Results: Themes that encapsulate the patient experience will be identified from qualitative evidence, and these themes will shed light on the perceived benefits and disadvantages, usability, acceptability, and the overall impact digital tools can have on the lives of those with chronic pain. Conclusions: This systematic review will identify, appraise, and synthesize the overall experience of patients engaging in DHI to manage a diverse range of chronic pain conditions. By elaborating the patient experience through qualitative analysis, the findings from this review will enhance our current understanding of the experiences of patients with chronic pain using digital tools for the self-management of their pain and highlight what person-centered elements are essential for future DHI development. Trial Registration: PROSPERO CRD42023445100; http://tinyurl.com/4z77khfs International Registered Report Identifier (IRRID): DERR1-10.2196/52469 UR - https://www.researchprotocols.org/2024/1/e52469 UR - http://dx.doi.org/10.2196/52469 UR - http://www.ncbi.nlm.nih.gov/pubmed/38451694 ID - info:doi/10.2196/52469 ER - TY - JOUR AU - McCartney, Haruno AU - Main, Ashleigh AU - Ibrar, Maryam AU - Rai, Kaur Harleen AU - Weir, McFayden Natalie AU - Maguire, Roma PY - 2024/3/5 TI - Professional-Facing Digital Health Solutions for the Care of Patients With Chronic Pain: Protocol for a Systematic Scoping Review JO - JMIR Res Protoc SP - e51311 VL - 13 KW - burden KW - chronic pain KW - clinician KW - digital health solution KW - digital health KW - digital solutions KW - eHealth KW - healthcare professional KW - mHealth KW - pain management KW - patient-facing KW - risk factor N2 - Background: Chronic pain is a highly prevalent condition and one of the most common reasons why people seek health care. As a result, chronic pain has a significant personal and economic burden. The COVID-19 pandemic has aggravated the situation for patients with chronic pain through increased risk factors (eg, anxiety or depression) as well as decreased access to health care. Digital health solutions to support people with chronic pain are becoming increasingly popular. Most of the research has focused on patient-facing digital health solutions, although it is clear that the involvement of health and care professionals is crucial in chronic pain care. Certainly, digital health solutions intended for the use of health and care professionals in the care of patients with chronic pain (ie, professional facing) exist, for example, for clinical decision support; however, no review has investigated the studies reporting these interventions. Objective: The overall aim of this scoping review is to identify the available professional-facing digital health solutions for the purpose of chronic pain management. The objectives of this review are to investigate the components, target populations, and user settings of the available professional-facing digital solutions; health and care professionals? perspectives on using digital health solutions (if reported); the methods in which the digital health solutions are developed; and the outcomes of using professional-facing digital health solutions. Methods: Databases including MEDLINE, Embase, CINAHL, PsycInfo, and Inspec will be searched for studies reporting professional-facing digital health solutions for chronic pain care, using a comprehensive search strategy developed for each of the specific databases. A total of 2 independent reviewers will screen the titles and abstracts for review inclusion and then conduct full-text screening. Any conflicts in study inclusion will be resolved by a third reviewer at each stage of the screening process. Following data extraction and quality assessment, a qualitative content analysis of the results will be conducted. This review will identify the available professional-facing digital health solutions for chronic pain management. The results of this review are likely to be heterogeneous in terms of content (ie, the digital solutions will serve a variety of purposes, settings, target populations, etc) and methods (ie, experimental and nonexperimental designs). Results: The review is expected to finish in March 2024 and published in the summer of 2024. Conclusions: This protocol outlines the need for a scoping review to identify professional-facing digital health solutions for the management of chronic pain. Results from this review will contribute to the growing field of research into the utility of digital health for chronic pain management. International Registered Report Identifier (IRRID): DERR1-10.2196/51311 UR - https://www.researchprotocols.org/2024/1/e51311 UR - http://dx.doi.org/10.2196/51311 UR - http://www.ncbi.nlm.nih.gov/pubmed/38441946 ID - info:doi/10.2196/51311 ER - TY - JOUR AU - Li, Ran AU - Li, Yinghao AU - Kong, Youli AU - Li, Hanbin AU - Hu, Danrong AU - Fu, Chenying AU - Wei, Quan PY - 2024/2/26 TI - Virtual Reality?Based Training in Chronic Low Back Pain: Systematic Review and Meta-Analysis of Randomized Controlled Trials JO - J Med Internet Res SP - e45406 VL - 26 KW - virtual reality KW - low back pain KW - chronic KW - rehabilitation KW - exercise N2 - Background: Low back pain is one of the most prevalent pain conditions worldwide. Virtual reality?based training has been used for low back pain as a new treatment strategy. Present evidence indicated that the effectiveness of virtual reality?based training for people with chronic low back pain is inconclusive. Objective: This study conducted a meta-analysis to evaluate the immediate- and short-term effects of virtual reality?based training on pain, pain-related fear, and disability in people with chronic low back pain. Methods: We searched the PubMed, Embase, Web of Science, PEDro, CENTRAL, and CINAHL databases from inception until January 2024. Only randomized controlled trials assessing the effects of virtual reality?based training on individuals with chronic low back pain were selected. The outcomes were focused on pain, pain-related fear measured by the Tampa Scale of Kinesiophobia, and disability measured by the Oswestry Disability Index. The immediate term was defined as the immediate period after intervention, and the short term was defined as 3 to 6 months after intervention. The Cochrane Risk of Bias tool and the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach were used to evaluate the quality of the methodology and evidence, respectively. Results: In total, 20 randomized controlled trials involving 1059 patients were eligible for analysis. Virtual reality?based training showed significant improvements in pain (mean difference [MD] ?1.43; 95% CI ?1.86 to ?1.00; I2=95%; P<.001), pain-related fear using the Tampa Scale of Kinesiophobia (MD ?5.46; 95% CI ?9.40 to 1.52; I2=90%; P=.007), and disability using the Oswestry Disability Index (MD ?11.50; 95% CI ?20.00 to ?3.01; I2=95%; P=.008) in individuals with chronic low back pain immediately after interventions. However, there were no significant differences observed in pain (P=.16), pain-related fear (P=.10), and disability (P=.43) in the short term. Conclusions: These findings indicated that virtual reality?based training can be used effectively for individuals with chronic low back pain in the immediate term, especially to reduce pain, alleviate pain-related fear, and improve disability. However, the short-term benefits need more high-quality trials to be demonstrated. Trial Registration: PROSPERO CRD42021292633; http://tinyurl.com/25mydxpz UR - https://www.jmir.org/2024/1/e45406 UR - http://dx.doi.org/10.2196/45406 UR - http://www.ncbi.nlm.nih.gov/pubmed/38407948 ID - info:doi/10.2196/45406 ER - TY - JOUR AU - Saby, Adam AU - Alvarez, Anthony AU - Smolins, David AU - Petros, James AU - Nguyen, Lincoln AU - Trujillo, Michael AU - Aygün, Oytun PY - 2024/2/16 TI - Effects of Embodiment in Virtual Reality for Treatment of Chronic Pain: Pilot Open-Label Study JO - JMIR Form Res SP - e34162 VL - 8 KW - centralized pain KW - dicentralized pain KW - digital therapeutics KW - visual analog scale KW - Fear-Avoidance Beliefs Questionnaire KW - Oswestry KW - Oswestry Low Back Pain Disability Questionnaire KW - Pain Catastrophizing Scale KW - Patient Health Questionnaire KW - sensorimotor KW - virtual reality KW - chronic pain KW - pain KW - rehabilitation N2 - Background: Chronic pain has long been a major health burden that has been addressed through numerous forms of pharmacological and nonpharmacological treatment. One of the tenets of modern medicine is to minimize risk while providing efficacy. Further, because of its noninvasive nature, virtual reality (VR) provides an attractive platform for potentially developing novel therapeutic modalities. Objective: The purpose of this study was to determine the feasibility of a novel VR-based digital therapy for the treatment of chronic pain. Methods: An open-label study assessed the feasibility of using virtual embodiment in VR to treat chronic pain. In total, 24 patients with chronic pain were recruited from local pain clinics and completed 8 sessions of a novel digital therapeutic that combines virtual embodiment with graded motor imagery to deliver functional rehabilitation exercises over the course of 4 weeks. Pain intensity as measured by a visual analog scale before and after each virtual embodiment training session was used as the primary outcome measure. Additionally, a battery of patient-reported pain questionnaires (Fear-Avoidance Beliefs Questionnaire, Oswestry Low Back Pain Disability Questionnaire, Pain Catastrophizing Scale, and Patient Health Questionnaire) were administered before and after 8 sessions of virtual embodiment training as exploratory outcome measures to assess if the measures are appropriate and warrant a larger randomized controlled trial. Results: A 2-way ANOVA on session × pre- versus postvirtual embodiment training revealed that individual virtual embodiment training sessions significantly reduced the intensity of pain as measured by the visual analog scale (P<.001). Perceived disability due to lower back pain as measured by the Oswestry Low Back Pain Disability Questionnaire significantly improved (P=.003) over the 4-week course of virtual embodiment regimen. Improvement was also observed on the helplessness subscale of the Pain Catastrophizing Scale (P=.02). Conclusions: This study provides evidence that functional rehabilitation exercises delivered in VR are safe and may have positive effects on alleviating the symptoms of chronic pain. Additionally, the virtual embodiment intervention may improve perceived disability and helplessness of patients with chronic pain after 8 sessions. The results support the justification for a larger randomized controlled trial to assess the extent to which virtual embodiment training can exert an effect on symptoms associated with chronic pain. Trial Registration: ClinicalTrials.gov NCT04060875; https://clinicaltrials.gov/ct2/show/NCT04060875 UR - https://formative.jmir.org/2024/1/e34162 UR - http://dx.doi.org/10.2196/34162 UR - http://www.ncbi.nlm.nih.gov/pubmed/38363591 ID - info:doi/10.2196/34162 ER - TY - JOUR AU - van der Horst, Annemieke AU - Meijer, Laura AU - van Os - Medendorp, Harmieke AU - Jukema, S. Jan AU - Bohlmeijer, Ernst AU - Schreurs, MG Karlein AU - Kelders, Saskia PY - 2024/2/7 TI - Benefits, Recruitment, Dropout, and Acceptability of the Strength Back Digital Health Intervention for Patients Undergoing Spinal Surgery: Nonrandomized, Qualitative, and Quantitative Pilot Feasibility Study JO - JMIR Form Res SP - e54600 VL - 8 KW - pilot feasibility study KW - spinal surgery KW - digital health intervention KW - positive psychology KW - acceptance and commitment therapy KW - mobile phone N2 - Background: Patients undergoing spinal surgery report high levels of insecurity, pain, stress, and anxiety before and after surgery. Unfortunately, there is no guarantee that surgery will resolve all issues; postsurgical recovery often entails moderate to severe postoperative pain, and some patients undergoing spinal surgery do not experience (long-term) pain relief after surgery. Therefore, focusing on sustainable coping skills and resilience is crucial for these patients. A digital health intervention based on acceptance and commitment therapy (ACT) and positive psychology (PP) was developed to enhance psychological flexibility and well-being and reduce postsurgical pain. Objective: The objective of this study was 3-fold: to explore the potential benefits for patients undergoing spinal surgery of the digital ACT and PP intervention Strength Back (research question [RQ] 1), explore the feasibility of a future randomized controlled trial in terms of recruitment and dropout (RQ 2), and assess the acceptability of Strength Back by patients undergoing spinal surgery (RQ 3). Methods: We used a nonrandomized experimental design with an intervention group (n=17) and a control group (n=20). To explore the potential benefits of the intervention, participants in both groups filled out questionnaires before and after surgery. These questionnaires included measurements of pain intensity (Numeric Pain Rating Scale), pain interference (Multidimensional Pain Inventory), anxiety and depression (Hospital Anxiety and Depression Scale), valued living (Engaged Living Scale), psychological flexibility (Psychological Inflexibility in Pain Scale), and mental well-being (Mental Health Continuum?Short Form). Semistructured interviews combined with log data and scores on the Twente Engagement With eHealth Technologies Scale were used to assess the acceptability of the intervention. Results: A significant improvement over time in emotional (V=99; P=.03) and overall (V=55; P=.004) well-being (Mental Health Continuum?Short Form) was observed only in the intervention group. In addition, the intervention group showed a significantly larger decline in pain intensity (Numeric Pain Rating Scale) than did the control group (U=75; P=.003). Of the available weekly modules on average 80% (12/15) was completed by patients undergoing spinal fusion and 67% (6/9) was completed by patients undergoing decompression surgery. A total of 68% (17/25) of the participants used the intervention until the final interview. Most participants (15/17, 88%) in the intervention group would recommend the intervention to future patients. Conclusions: This pilot feasibility study showed that combining ACT and PP in a digital health intervention is promising for patients undergoing spinal surgery as the content was accepted by most of the participants and (larger) improvements in pain intensity and well-being were observed in the intervention group. A digital intervention for patients undergoing (spinal) surgery can use teachable moments, when patients are open to learning more about the surgery and rehabilitation afterward. A larger randomized controlled trial is now warranted. UR - https://formative.jmir.org/2024/1/e54600 UR - http://dx.doi.org/10.2196/54600 UR - http://www.ncbi.nlm.nih.gov/pubmed/38324374 ID - info:doi/10.2196/54600 ER - TY - JOUR AU - Fudickar, Sebastian AU - Bantel, Carsten AU - Spieker, Jannik AU - Töpfer, Heinrich AU - Stegeman, Patrick AU - Schiphorst Preuper, R. Henrica AU - Reneman, F. Michiel AU - Wolff, P. André AU - Soer, Remko PY - 2024/1/30 TI - Natural Language Processing of Referral Letters for Machine Learning?Based Triaging of Patients With Low Back Pain to the Most Appropriate Intervention: Retrospective Study JO - J Med Internet Res SP - e46857 VL - 26 KW - decision support KW - triaging KW - NLP KW - natural language processing KW - neural network KW - LBP KW - low back pain KW - back KW - pain KW - decision-making KW - machine learning KW - artificial intelligence KW - clinical application KW - patient records KW - qualitative data KW - support system KW - questionnaire KW - quality of life KW - psychosocial N2 - Background: Decision support systems (DSSs) for suggesting optimal treatments for individual patients with low back pain (LBP) are currently insufficiently accurate for clinical application. Most of the input provided to train these systems is based on patient-reported outcome measures. However, with the appearance of electronic health records (EHRs), additional qualitative data on reasons for referrals and patients? goals become available for DSSs. Currently, no decision support tools cover a wide range of biopsychosocial factors, including referral letter information to help clinicians triage patients to the optimal LBP treatment. Objective: The objective of this study was to investigate the added value of including qualitative data from EHRs and referral letters to the accuracy of a quantitative DSS for patients with LBP. Methods: A retrospective study was conducted in a clinical cohort of Dutch patients with LBP. Patients filled out a baseline questionnaire about demographics, pain, disability, work status, quality of life, medication, psychosocial functioning, comorbidity, history, and duration of pain. Referral reasons and patient requests for help (patient goals) were extracted via natural language processing (NLP) and enriched in the data set. For decision support, these data were considered independent factors for triage to neurosurgery, anesthesiology, rehabilitation, or minimal intervention. Support vector machine, k-nearest neighbor, and multilayer perceptron models were trained for 2 conditions: with and without consideration of the referral letter content. The models? accuracies were evaluated via F1-scores, and confusion matrices were used to predict the treatment path (out of 4 paths) with and without additional referral parameters. Results: Data from 1608 patients were evaluated. The evaluation indicated that 2 referral reasons from the referral letters (for anesthesiology and rehabilitation intervention) increased the F1-score accuracy by up to 19.5% for triaging. The confusion matrices confirmed the results. Conclusions: This study indicates that data enriching by adding NLP-based extraction of the content of referral letters increases the model accuracy of DSSs in suggesting optimal treatments for individual patients with LBP. Overall model accuracies were considered low and insufficient for clinical application. UR - https://www.jmir.org/2024/1/e46857 UR - http://dx.doi.org/10.2196/46857 UR - http://www.ncbi.nlm.nih.gov/pubmed/38289669 ID - info:doi/10.2196/46857 ER - TY - JOUR AU - Nestor, A. Bridget AU - Chimoff, Justin AU - Koike, Camila AU - Weitzman, R. Elissa AU - Riley, L. Bobbie AU - Uhl, Kristen AU - Kossowsky, Joe PY - 2024/1/11 TI - Adolescent and Parent Perspectives on Digital Phenotyping in Youths With Chronic Pain: Cross-Sectional Mixed Methods Survey Study JO - J Med Internet Res SP - e47781 VL - 26 KW - acceptability KW - adolescent KW - chronic pain KW - digital phenotyping KW - mobile health KW - pediatric N2 - Background: Digital phenotyping is a promising methodology for capturing moment-to-moment data that can inform individually adapted and timely interventions for youths with chronic pain. Objective: This study aimed to investigate adolescent and parent endorsement, perceived utility, and concerns related to passive data stream collection through smartphones for digital phenotyping for clinical and research purposes in youths with chronic pain. Methods: Through multiple-choice and open-response survey questions, we assessed the perspectives of patient-parent dyads (103 adolescents receiving treatment for chronic pain at a pediatric hospital with an average age of 15.6, SD 1.6 years, and 99 parents with an average age of 47.8, SD 6.3 years) on passive data collection from the following 9 smartphone-embedded passive data streams: accelerometer, apps, Bluetooth, SMS text message and call logs, keyboard, microphone, light, screen, and GPS. Results: Quantitative and qualitative analyses indicated that adolescents and parent endorsement and perceived utility of digital phenotyping varied by stream, though participants generally endorsed the use of data collected by passive stream (35%-75.7% adolescent endorsement for clinical use and 37.9%-74.8% for research purposes; 53.5%-81.8% parent endorsement for clinical and 52.5%-82.8% for research purposes) if a certain level of utility could be provided. For adolescents and parents, adjusted logistic regression results indicated that the perceived utility of each stream significantly predicted the likelihood of endorsement of its use in both clinical practice and research (Ps<.05). Adolescents and parents alike identified accelerometer, light, screen, and GPS as the passive data streams with the highest utility (36.9%-47.5% identifying streams as useful). Similarly, adolescents and parents alike identified apps, Bluetooth, SMS text message and call logs, keyboard, and microphone as the passive data streams with the least utility (18.5%-34.3% identifying streams as useful). All participants reported primary concerns related to privacy, accuracy, and validity of the collected data. Passive data streams with the greatest number of total concerns were apps, Bluetooth, call and SMS text message logs, keyboard, and microphone. Conclusions: Findings support the tailored use of digital phenotyping for this population and can help refine this methodology toward an acceptable, feasible, and ethical implementation of real-time symptom monitoring for assessment and intervention in youths with chronic pain. UR - https://www.jmir.org/2024/1/e47781 UR - http://dx.doi.org/10.2196/47781 UR - http://www.ncbi.nlm.nih.gov/pubmed/38206665 ID - info:doi/10.2196/47781 ER - TY - JOUR AU - Ota, Hirofumi AU - Mukaino, Masahiko AU - Inoue, Yukari AU - Matsuura, Shoh AU - Yagi, Senju AU - Kanada, Yoshikiyo AU - Saitoh, Eiichi AU - Otaka, Yohei PY - 2023/12/5 TI - Movement Component Analysis of Reaching Strategies in Individuals With Stroke: Preliminary Study JO - JMIR Rehabil Assist Technol SP - e50571 VL - 10 KW - stroke KW - upper limb paresis KW - compensatory movements KW - three-dimensional motion analysis KW - reaching movement KW - rehabilitation KW - motion analysis KW - reaching KW - 3D KW - three dimensional KW - motion capture KW - motion KW - movement KW - limb KW - extremity KW - extremities KW - mobility KW - hemiparesis KW - paralysis KW - compensate KW - compensatory N2 - Background: Upper limb motor paresis is a major symptom of stroke, which limits activities of daily living and compromises the quality of life. Kinematic analysis offers an in-depth and objective means to evaluate poststroke upper limb paresis, with anticipation for its effective application in clinical settings. Objective: This study aims to compare the movement strategies of patients with hemiparesis due to stroke and healthy individuals in forward reach and hand-to-mouth reach, using a simple methodology designed to quantify the contribution of various movement components to the reaching action. Methods: A 3D motion analysis was conducted, using a simplified marker set (placed at the mandible, the seventh cervical vertebra, acromion, lateral epicondyle of the humerus, metacarpophalangeal [MP] joint of the index finger, and greater trochanter of the femur). For the forward reach task, we measured the distance the index finger?s MP joint traveled from its starting position to the forward target location on the anterior-posterior axis. For the hand-to-mouth reach task, the shortening of the vertical distance between the index finger MP joint and the position of the chin at the start of the measurement was measured. For both measurements, the contributions of relevant upper limb and trunk movements were calculated. Results: A total of 20 healthy individuals and 10 patients with stroke participated in this study. In the forward reach task, the contribution of shoulder or elbow flexion was significantly smaller in participants with stroke than in healthy participants (mean 52.5%, SD 24.5% vs mean 85.2%, SD 4.5%; P<.001), whereas the contribution of trunk flexion was significantly larger in stroke participants than in healthy participants (mean 34.0%, SD 28.5% vs mean 3.0%, SD 2.8%; P<.001). In the hand-to-mouth reach task, the contribution of shoulder or elbow flexion was significantly smaller in participants with stroke than in healthy participants (mean 71.8%, SD 23.7% vs mean 90.7%, SD 11.8%; P=.009), whereas shoulder girdle elevation and shoulder abduction were significantly larger in participants with stroke than in healthy participants (mean 10.5%, SD 5.7% vs mean 6.5%, SD 3.0%; P=.02 and mean 16.5%, SD 18.7% vs mean 3.0%, SD 10.4%; P=.02, respectively). Conclusions: Compared with healthy participants, participants with stroke achieved a significantly greater distance via trunk flexion in the forward reach task and shoulder abduction and shoulder girdle elevation in the hand-to-mouth reach task, both of these differences are regarded as compensatory movements. Understanding the characteristics of individual motor strategies, such as dependence on compensatory movements, may contribute to tailored goal setting in stroke rehabilitation. UR - https://rehab.jmir.org/2023/1/e50571 UR - http://dx.doi.org/10.2196/50571 UR - http://www.ncbi.nlm.nih.gov/pubmed/38051570 ID - info:doi/10.2196/50571 ER - TY - JOUR AU - Cheng, L. Abby AU - Agarwal, Mansi AU - Armbrecht, A. Melissa AU - Abraham, Joanna AU - Calfee, P. Ryan AU - Goss, W. Charles PY - 2023/11/17 TI - Behavioral Mechanisms That Mediate Mental and Physical Health Improvements in People With Chronic Pain Who Receive a Digital Health Intervention: Prospective Cohort Pilot Study JO - JMIR Form Res SP - e51422 VL - 7 KW - digital mental health intervention KW - chronic musculoskeletal pain KW - anxiety KW - depression KW - pain interference KW - physical function KW - behavioral activation KW - pain acceptance KW - sleep quality KW - mediation analysis KW - behavioral mechanism KW - chronic pain KW - digital health intervention KW - mobile phone N2 - Background: Preliminary evidence suggests that digital mental health intervention (Wysa for Chronic Pain) can improve mental and physical health in people with chronic musculoskeletal pain and coexisting symptoms of depression or anxiety. However, the behavioral mechanisms through which this intervention acts are not fully understood. Objective: The purpose of this study was to identify behavioral mechanisms that may mediate changes in mental and physical health associated with use of Wysa for Chronic Pain during orthopedic management of chronic musculoskeletal pain. We hypothesized that improved behavioral activation, pain acceptance, and sleep quality mediate improvements in self-reported mental and physical health. Methods: In this prospective cohort, pilot mediation analysis, adults with chronic (?3 months) neck or back pain received the Wysa for Chronic Pain digital intervention, which uses a conversational agent and text-based access to human counselors to deliver cognitive behavioral therapy and related therapeutic content. Patient-reported outcomes and proposed mediators were collected at baseline and 1 month. The exposure of interest was participants? engagement (ie, total interactions) with the digital intervention. Proposed mediators were assessed using the Behavioral Activation for Depression Scale?Short Form, Chronic Pain Acceptance Questionnaire, and Athens Insomnia Scale. Outcomes included Patient-Reported Outcomes Measurement Information System Anxiety, Depression, Pain Interference, and Physical Function scores. A mediation analysis was conducted using the Baron and Kenny method, adjusting for age, sex, and baseline mediators and outcome values. P<.20 was considered significant for this pilot study. Results: Among 30 patients (mean age 59, SD 14, years; 21 [70%] female), the mediation effect of behavioral activation on the relationship between increased intervention engagement and improved anxiety symptoms met predefined statistical significance thresholds (indirect effect ?0.4, 80% CI ?0.7 to ?0.1; P=.13, 45% of the total effect). The direction of mediation effect was generally consistent with our hypothesis for all other proposed mediator or outcome relationships, as well. Conclusions: In a full-sized randomized controlled trial of patients with chronic musculoskeletal pain, behavioral activation, pain acceptance, and sleep quality may play an important role in mediating the relationship between use of a digital mental health intervention (Wysa for Chronic Pain) and improved mental and physical health. Trial Registration: ClinicalTrials.gov NCT05194722; https://clinicaltrials.gov/ct2/show/NCT05194722 UR - https://formative.jmir.org/2023/1/e51422 UR - http://dx.doi.org/10.2196/51422 UR - http://www.ncbi.nlm.nih.gov/pubmed/37976097 ID - info:doi/10.2196/51422 ER - TY - JOUR AU - Conti, Lorenzo AU - Marzorati, Chiara AU - Grasso, Roberto AU - Ferrucci, Roberta AU - Priori, Alberto AU - Mameli, Francesca AU - Ruggiero, Fabiana AU - Pravettoni, Gabriella PY - 2023/11/16 TI - Home-Based Treatment for Chronic Pain Combining Neuromodulation, Computer-Assisted Training, and Telemonitoring in Patients With Breast Cancer: Protocol for a Rehabilitative Study JO - JMIR Res Protoc SP - e49508 VL - 12 KW - telemedicine KW - chronic pain KW - breast cancer KW - tDCS KW - transcranial direct current stimulation KW - home care treatment KW - home care KW - care KW - training KW - pain KW - cancer KW - quality of life KW - rehabilitation KW - telemonitoring KW - web platform KW - exercise KW - therapy N2 - Background: Chronic pain is a disabling symptom frequently reported in patients with breast cancer with a prevalence ranging from 25% to 60%, representing a major health issue. It has negative consequences on health status, causing psychological distress and affecting quality of life. Furthermore, the clinical management of chronic pain is often inadequate, and many patients do not benefit from the administration of pharmacological treatments. Alternative therapeutic options have been implemented to improve the psychophysical well-being of patients, including neuromodulation and complementary interventions. Objective: We aimed to investigate the effectiveness of a home care strategy combining computerized rehabilitation, transcranial direct current stimulation (tDCS), and remote telemonitoring via a web-based platform in patients with breast cancer suffering for chronic pain. Methods: A web-based structured survey aimed at monitoring chronic pain and its effect on psychological functions will be delivered to patients with breast cancer through social media and email. In total, 42 patients with breast cancer affected by chronic pain will be recruited during the medical screening visit. The patients will be randomly divided into 3 treatment groups that will carry out either tDCS only, exercise therapy only, or a combination of both over a 3-week period. All the treatments will be delivered at the patients? home through the use of a system including a tablet, wearable inertial sensors, and a tDCS programmable medical device. Using web-based questionnaires, the perception of pain (based on the pain self-efficacy questionnaire, visual analogue scale, pain catastrophizing scale, and brief pain inventory) and psychological variables (based on the hospital and anxiety depression scale and 12-item short form survey) will be assessed at the beginning of treatment, 1 week after the start of treatment, at the end of treatment, 1 month after the start of treatment, and 3 months after the start of treatment. The system?s usability (based on the mobile app rating scale and system usability scale) and its involvement in the decision-making process (based on the 9-item shared decision-making questionnaire) will be also evaluated. Finally, at the end of the treatment, a digital focus group will be conducted with the 42 patients to explore their unexpressed needs and preferences concerning treatment. Results: The study project is scheduled to start in June 2023, and it is expected to be completed by August 2025. Conclusions: We expect that the combination of tDCS and telemedicine programs will reduce pain perceived by patients with breast cancer and improve their mental well-being more effectively than single interventions. Furthermore, we assume that this home-based approach will also improve patients? participation in routine clinical care, reducing disparities in accessing health care processes. This integrated home care strategy could be useful for patients with breast cancer who cannot find relief from chronic pain with pharmacological treatments or for those who have limited access to care due to poor mobility or geographical barriers, thus increasing the patients? empowerment and reducing health care costs. International Registered Report Identifier (IRRID): PRR1-10.2196/49508 UR - https://www.researchprotocols.org/2023/1/e49508 UR - http://dx.doi.org/10.2196/49508 UR - http://www.ncbi.nlm.nih.gov/pubmed/37971805 ID - info:doi/10.2196/49508 ER - TY - JOUR AU - Abahussin, A. Asma AU - West, M. Robert AU - Wong, C. David AU - Ziegler, E. Lucy AU - Allsop, J. Matthew PY - 2023/10/9 TI - Supporting Pain Self-Management in Patients With Cancer: App Development Based on a Theoretical and Evidence-Driven Approach JO - JMIR Cancer SP - e49471 VL - 9 KW - pain KW - cancer KW - behavior change KW - capability, opportunity, motivation, and behavior model KW - COM-B model KW - Behavior Change Wheel KW - BCW KW - mobile health KW - mHealth KW - app KW - pain self-management KW - evidence-based KW - intervention design KW - theory N2 - Background: To inform the development of an intervention, it is essential to have a well-developed theoretical understanding of how an intervention causes change, as stated in the UK Medical Research Council guidelines for developing complex interventions. Theoretical foundations are often ignored in the development of mobile health apps intended to support pain self-management for patients with cancer. Objective: This study aims to systematically set a theory- and evidence-driven design for a pain self-management app and specify the app?s active features. Methods: The Behavior Change Wheel (BCW) framework, a step-by-step theoretical approach to the development of interventions, was adopted to achieve the aim of this study. This started by understanding and identifying sources of behavior that could be targeted to support better pain management. Ultimately, the application of the BCW framework guided the identification of the active contents of the app, which were characterized using the Behavior Change Technique Taxonomy version 1. Results: The theoretical analysis revealed that patients may have deficits in their capability, opportunity, and motivation that prevent them from performing pain self-management. The app needs to use education, persuasion, training, and enablement intervention functions because, based on the analysis, they were found the most likely to address the specified factors. Eighteen behavior change techniques were selected to describe precisely how the intervention functions can be presented to induce the desired change regarding the intervention context. In other words, they were selected to form the active contents of the app, potentially reducing barriers and serving to support patients in the self-management of pain while using the app. Conclusions: This study fully reports the design and development of a pain self-management app underpinned by theory and evidence and intended for patients with cancer. It provides a model example of the BCW framework application for health app development. The work presented in this study is the first systematic theory- and evidence-driven design for a pain app for patients with cancer. This systematic approach can support clarity in evaluating the intervention?s underlying mechanisms and support future replication. UR - https://cancer.jmir.org/2023/1/e49471 UR - http://dx.doi.org/10.2196/49471 UR - http://www.ncbi.nlm.nih.gov/pubmed/37812491 ID - info:doi/10.2196/49471 ER - TY - JOUR AU - Haun, N. Jolie AU - Venkatachalam, H. Hari AU - Fowler, A. Christopher AU - Alman, C. Amy AU - Ballistrea, M. Lisa AU - Schneider, Tali AU - Benzinger, C. Rachel AU - Melillo, Christine AU - Alexander, B. Neil AU - Klanchar, Angelina S. AU - Lapcevic, William AU - French, D. Dustin PY - 2023/10/3 TI - Mobile and Web-Based Partnered Intervention to Improve Remote Access to Pain and Posttraumatic Stress Disorder Symptom Management: Recruitment and Attrition in a Randomized Controlled Trial JO - J Med Internet Res SP - e49678 VL - 25 KW - PTSD KW - pain KW - veteran KW - attrition KW - CIH KW - randomized controlled trial KW - chronic pain KW - remote intervention KW - dyad KW - mobile health N2 - Background: Increasing access to nonpharmacological interventions to manage pain and posttraumatic stress disorder (PTSD) is essential for veterans. Complementary and integrative health (CIH) interventions can help individuals manage symptom burden with enhanced accessibility via remotely delivered health care. Mission Reconnect (MR) is a partnered, self-directed intervention that remotely teaches CIH skills. Objective: The purpose of this paper is to describe the recruitment, onboarding phase, and attrition of a fully remote randomized controlled trial (RCT) assessing the efficacy of a self-directed mobile and web-based intervention for veterans with comorbid chronic pain and PTSD and their partners. Methods: A total of 364 veteran-partner dyads were recruited to participate in a mixed methods multisite waitlist control RCT. Qualitative attrition interviews were conducted with 10 veterans with chronic pain and PTSD, and their self-elected partners (eg, spouse) who consented but did not begin the program. Results: At the point of completing onboarding and being randomized to the 2 treatment arms, of the 364 recruited dyads, 97 (26.6%) failed to complete onboarding activities. Reported reasons for failure to complete onboarding include loss of self-elected partner buy-in (n=8, 8%), difficulties with using remote data collection methods and interventions (n=30, 31%), and adverse health experiences unrelated to study activities (n=23, 24%). Enrolled veterans presented at baseline with significant PTSD symptom burden and moderate-to-severe pain severity, and represented a geographically and demographically diverse population. Attrition interviews (n=10) indicated that misunderstanding MR including the intent of the intervention or mistaking the surveys as the actual intervention was a reason for not completing the MR registration process. Another barrier to MR registration was that interviewees described the mailed study information and registration packets as too confusing and excessive. Competing personal circumstances including health concerns that required attention interfered with MR registration. Common reasons for attrition following successful MR registration included partner withdrawal, adverse health issues, and technological challenges relating to the MR and electronic data collection platform (Qualtrics). Participant recommendations for reducing attrition included switching to digital forms to reduce participant burden and increasing human interaction throughout the registration and baseline data collection processes. Conclusions: Challenges, solutions, and lessons learned for study recruitment and intervention delivery inform best practices of delivering remote self-directed CIH interventions when addressing the unique needs of this medically complex population. Successful recruitment and enrollment of veterans with chronic pain and PTSD, and their partners, to remote CIH programs and research studies requires future examination of demographic and symptom-associated access barriers. Accommodating the unique needs of this medically complex population is essential for improving the effectiveness of CIH programs. Disseminating lessons learned and improving access to remotely delivered research studies and CIH programs is paramount in the post?COVID-19 climate. Trial Registration: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 UR - https://www.jmir.org/2023/1/e49678 UR - http://dx.doi.org/10.2196/49678 UR - http://www.ncbi.nlm.nih.gov/pubmed/37788078 ID - info:doi/10.2196/49678 ER - TY - JOUR AU - Afzal, Waqar M. AU - Ahmad, Ashfaq AU - Hanif, Bilal Hafiz Muhammad AU - Chaudhary, Nauman AU - Gilani, Amir Syed PY - 2023/9/15 TI - Effects of Virtual Reality Exercises on Chronic Low Back Pain: Quasi-Experimental Study JO - JMIR Rehabil Assist Technol SP - e43985 VL - 10 KW - low back pain, lumbar range of motion KW - pain KW - Oswestry disability index KW - virtual reality KW - exercise KW - back pain KW - lumbar KW - range of motion KW - VR KW - rehabilitation KW - gaming KW - serious game N2 - Background: Low back pain is a common health problem globally. Based on the duration of pain, it is classified as acute, subacute, or chronic low back pain. Different treatment strategies are available to reduce chronic low back pain. Virtual reality (VR) is a novel approach in back pain rehabilitation. Objective: This study aimed to compare the effects of VR games on chronic low back pain. Methods: This quasi-experimental study was conducted among 40 patients with chronic low back pain. The data were collected using a nonprobability, convenient sampling technique. Patients visiting the Department of Physiotherapy, Government Services Hospital, Lahore, Pakistan, were recruited and equally divided into 4 groups. Group A received the Reflex Ridge game; group B received the Body Ball game; group C combined the 2 games without back-strengthening exercises; and group D combined the 2 games with back-strengthening exercises. The participants received 8 treatment sessions, with 3 sessions/wk. The outcomes were pre- and posttest measurements of pain intensity, low back disability, and lumbar range of motion. The repeated measurement ANOVA was used for inter- and intragroup comparison, with significance at P?.05. Results: The study comprised a sample of 40 patients with low back pain; 12 (40%) were female and 28 (60%) were male, with a mean age of 37.85 (SD 12.15) years. The pre- and posttest mean pain scores were 7.60 (SD 1.84) and 4.20 (SD 1.62) in group A, 6.60 (SD 1.776) and 5.90 (SD 1.73) in group B, 6.90 (SD 1.73) and 5.40 (SD 1.07) in group C, and 7.10 (SD 1.53) and 3.60 (SD 0.97) in group D, respectively. The mean pain score differences of group D (combining the Reflex Ridge and Body Ball games with back-strengthening exercises) compared to groups A, B, and C were ?.60 (P=.76), ?2.30 (P<.001), and ?1.80 (P=.03), respectively. Regarding the range of motion, the forward lumbar flexion mean differences of group D compared to groups A, B, and C were 3.80 (P=.21), 4.80 (P=.07), and 7.40 (P<.001), respectively. Similarly, the right lateral lumbar flexion mean differences of group D compared to groups A, B, and C were 2.80 (P=.04), 5.20 (P<.001), and 4.80 (P<.001), respectively. The left lateral lumbar flexion mean differences of group D compared to groups A, B, and C were 2.80 (P<.001), 4.80 (P=.02), and 2.20 (P<.001). respectively, showing significant pre- and posttreatment effects. Conclusions: VR exercises had statistically significant effects on improving pain, low back disability, and range of motion in all groups, but the combination of Reflex Ridge and Body Ball games with back-strengthening exercises had dominant effects compared to the other groups. Trial Registration: Iranian Registry of Clinical Trial IRCT20200330046895N1; https://en.irct.ir/trial/46916 UR - https://rehab.jmir.org/2023/1/e43985 UR - http://dx.doi.org/10.2196/43985 UR - http://www.ncbi.nlm.nih.gov/pubmed/37713252 ID - info:doi/10.2196/43985 ER - TY - JOUR AU - Sang, Ling AU - Song, Li PY - 2023/9/11 TI - The Current Status of the Use of Internet Hospitals for Outpatients With Pain: Retrospective Study JO - J Med Internet Res SP - e44759 VL - 25 KW - internet hospital KW - internet + KW - pain management KW - online visit KW - outpatient KW - pain N2 - Background: The national ?Internet +? policies and the emergence of internet hospitals have created a new direction for the management of pain outside of the hospital. Nevertheless, there are no consolidated studies conducted by pain physicians on the current state of internet hospital?based online medical services used by patients with pain outside of a hospital setting. Objective: In this retrospective study, we aimed to examine the status of the use of internet hospitals by patients who experience pain. Moreover, we identified the factors that influenced patients' decisions to make an online visit through the internet hospital. Methods: Detailed information was collected online and offline from outpatients with pain at the information technology center of West China Hospital of Sichuan University from February 2020 to April 2022. Binary logistic regression analysis was conducted to identify the determinants that influenced patients' decisions to make an online visit to the internet hospital. Results: Over a 2-year period, 85,266 pain-related clinic visits were recorded. Ultimately, 39,260 patients were enrolled for the analysis, with 12.9% (5088/39,260) having online visits. Both online and offline clinics had a greater number of visits by women than men. The average age of patients attending the online clinic was 46.85 (SD 16.56) years, whereas the average age of patients attending the offline clinic was 51.48 (SD 16.12) years. The majority of online clinic visitors (3059/5088, 60.1%) were employed, and one of the most common occupations was farming (721/5088, 14.2%). In addition, 51.8% (2635/5088) of patients who participated in the online clinics lived outside the hospital vicinity. Young (odds ratio [OR] 1.35, 95% CI 1.01-1.81; P=.045) and middle-aged (OR 1.98, 95% CI 1.81-2.16; P<.001) patients, employed patients (OR 1.11, 95% CI 1.04-1.18; P=.002), nonlocal patients (OR 1.57, 95% CI 1.48-1.67; P<.001), and the ordinary staff (OR 1.19, 95%CI 1.01-1.39; P=.03) were more likely to have the intention to choose online visits through the internet hospitals. Conclusions: Internet hospitals are flourishing as a more efficient and promising method of pain management and follow-up for patients with pain outside the hospital. People with pain who are young, working, and not in the vicinity of hospitals are more likely to visit internet hospitals. UR - https://www.jmir.org/2023/1/e44759 UR - http://dx.doi.org/10.2196/44759 UR - http://www.ncbi.nlm.nih.gov/pubmed/37695652 ID - info:doi/10.2196/44759 ER - TY - JOUR AU - Bostrøm, Katrine AU - Børøsund, Elin AU - Eide, Hilde AU - Varsi, Cecilie AU - Kristjansdottir, Birna Ólöf AU - Schreurs, G. Karlein M. AU - Waxenberg, B. Lori AU - Weiss, E. Karen AU - Morrison, J. Eleshia AU - Stavenes Støle, Hanne AU - Cvancarova Småstuen, Milada AU - Stubhaug, Audun AU - Solberg Nes, Lise PY - 2023/8/25 TI - Short-Term Findings From Testing EPIO, a Digital Self-Management Program for People Living With Chronic Pain: Randomized Controlled Trial JO - J Med Internet Res SP - e47284 VL - 25 KW - chronic pain KW - self-management KW - digital health KW - efficacy KW - cognitive behavioral therapy KW - acceptance and commitment therapy N2 - Background: Chronic pain conditions involve numerous physical and psychological challenges, and while psychosocial self-management interventions can be of benefit for people living with chronic pain, such in-person treatment is not always accessible. Digital self-management approaches could improve this disparity, potentially bolstering outreach and providing easy, relatively low-cost access to pain self-management interventions. Objective: This randomized controlled trial aimed to evaluate the short-term efficacy of EPIO (ie, inspired by the Greek goddess for the soothing of pain, Epione), a digital self-management intervention, for people living with chronic pain. Methods: Patients (N=266) were randomly assigned to either the EPIO intervention (n=132) or a care-as-usual control group (n=134). Outcome measures included pain interference (Brief Pain Inventory; primary outcome measure), anxiety and depression (Hospital Anxiety and Depression Scale), self-regulatory fatigue (Self-Regulatory Fatigue 18 scale), health-related quality of life (SF-36 Short Form Health Survey), pain catastrophizing (Pain Catastrophizing Scale), and pain acceptance (Chronic Pain Acceptance Questionnaire). Linear regression models used change scores as the dependent variables. Results: The participants were primarily female (210/259, 81.1%), with a median age of 49 (range 22-78) years and a variety of pain conditions. Analyses (n=229) after 3 months revealed no statistically significant changes for the primary outcome of pain interference (P=.84), but significant reductions in the secondary outcomes of depression (mean difference ?0.90; P=.03) and self-regulatory fatigue (mean difference ?2.76; P=.008) in favor of the intervention group. No other statistically significant changes were observed at 3 months (all P>.05). Participants described EPIO as useful (ie, totally agree or agree; 95/109, 87.2%) and easy to use (101/109, 92.7%), with easily understandable exercises (106/109, 97.2%). Conclusions: Evidence-informed, user-centered digital pain self-management interventions such as EPIO may have the potential to effectively support self-management and improve psychological functioning in the form of reduced symptoms of depression and improved capacity to regulate thoughts, feelings, and behavior for people living with chronic pain. Trial Registration: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104 UR - https://www.jmir.org/2023/1/e47284 UR - http://dx.doi.org/10.2196/47284 UR - http://www.ncbi.nlm.nih.gov/pubmed/37624622 ID - info:doi/10.2196/47284 ER - TY - JOUR AU - Pak, S. Sang AU - Janela, Dora AU - Freitas, Nina AU - Costa, Fabíola AU - Moulder, Robert AU - Molinos, Maria AU - Areias, C. Anabela AU - Bento, Virgílio AU - Cohen, P. Steven AU - Yanamadala, Vijay AU - Souza, B. Richard AU - Correia, Dias Fernando PY - 2023/8/18 TI - Comparing Digital to Conventional Physical Therapy for Chronic Shoulder Pain: Randomized Controlled Trial JO - J Med Internet Res SP - e49236 VL - 25 KW - chronic shoulder KW - clinical outcome KW - digital care KW - digital health intervention KW - musculoskeletal pain KW - pain management KW - physical therapy KW - remote sensing technology KW - telerehabilitation N2 - Background: Chronic shoulder pain (CSP) is a common condition with various etiologies, including rotator cuff disorders, adhesive capsulitis, shoulder instability, and shoulder arthritis. It is associated with substantial disability and psychological distress, resulting in poor productivity and quality of life. Physical therapy constitutes the mainstay treatment for CSP, but several barriers exist in accessing care. In recent years, telerehabilitation has gained momentum as a potential solution to overcome such barriers. It has shown numerous benefits, including improving access and convenience, promoting patient adherence, and reducing costs. However, to date, no previous randomized controlled trial has compared fully remote digital physical therapy to in-person rehabilitation for nonoperative CSP. Objective: The aim of this study is to compare clinical outcomes between digital physical therapy and conventional in-person physical therapy in patients with CSP. Methods: We conducted a single-center, parallel-group, randomized controlled trial involving 82 patients with CSP referred for outpatient physical therapy. Participants were randomized into digital or conventional physical therapy (8-week interventions). The digital intervention consisted of home exercise, education, and cognitive behavioral therapy (CBT), using a device with movement digitalization for biofeedback and asynchronous physical therapist monitoring through a cloud-based portal. The conventional group received in-person physical therapy, including exercises, manual therapy, education, and CBT. The primary outcome was the change (baseline to 8 weeks) in function and symptoms using the short-form of Disabilities of the Arm, Shoulder, and Hand questionnaire. Secondary outcome measures included self-reported pain, surgery intent, analgesic intake, mental health, engagement, and satisfaction. All questionnaires were delivered electronically. Results: A total of 90 participants were randomized into digital or conventional physical therapy, with 82 receiving the allocated intervention. Both groups experienced significant improvements in function measured by the short-form of the Disabilities of the Arm, Shoulder, and Hand questionnaire, with no differences between groups (?1.8, 95% CI ?13.5 to 9.8; P=.75). For secondary outcomes, no differences were observed in surgery intent, analgesic intake, and mental health or worst pain. Higher reductions were observed in average and least pain in the conventional group, which, given the small effect sizes (least pain 0.15 and average pain 0.16), are unlikely to be clinically meaningful. High adherence and satisfaction were observed in both groups, with no adverse events. Conclusions: This study shows that fully remote digital programs can be viable care delivery models for CSP given their scalability and effectiveness, assessed through comparison with high-dosage in-person rehabilitation. Trial Registration: ClinicalTrials.gov (NCT04636528); https://clinicaltrials.gov/study/NCT04636528 UR - https://www.jmir.org/2023/1/e49236 UR - http://dx.doi.org/10.2196/49236 UR - http://www.ncbi.nlm.nih.gov/pubmed/37490337 ID - info:doi/10.2196/49236 ER - TY - JOUR AU - Lewkowicz, Daniel AU - Bottinger, Erwin AU - Siegel, Martin PY - 2023/6/29 TI - Economic Evaluation of Digital Therapeutic Care Apps for Unsupervised Treatment of Low Back Pain: Monte Carlo Simulation JO - JMIR Mhealth Uhealth SP - e44585 VL - 11 KW - cost-utility analysis KW - cost KW - probabilistic sensitivity analysis KW - Monte Carlo simulation KW - low back pain KW - pain KW - economic KW - cost-effectiveness KW - Markov model KW - digital therapy KW - digital health app KW - mHealth, mobile health KW - health app KW - mobile app KW - orthopedic KW - QUALY KW - DALY KW - quality-adjusted life years KW - disability-adjusted life years KW - time horizon KW - veteran KW - statistics N2 - Background: Digital therapeutic care (DTC) programs are unsupervised app-based treatments that provide video exercises and educational material to patients with nonspecific low back pain during episodes of pain and functional disability. German statutory health insurance can reimburse DTC programs since 2019, but evidence on efficacy and reasonable pricing remains scarce. This paper presents a probabilistic sensitivity analysis (PSA) to evaluate the efficacy and cost-utility of a DTC app against treatment as usual (TAU) in Germany. Objective: The aim of this study was to perform a PSA in the form of a Monte Carlo simulation based on the deterministic base case analysis to account for model assumptions and parameter uncertainty. We also intend to explore to what extent the results in this probabilistic analysis differ from the results in the base case analysis and to what extent a shortage of outcome data concerning quality-of-life (QoL) metrics impacts the overall results. Methods: The PSA builds upon a state-transition Markov chain with a 4-week cycle length over a model time horizon of 3 years from a recently published deterministic cost-utility analysis. A Monte Carlo simulation with 10,000 iterations and a cohort size of 10,000 was employed to evaluate the cost-utility from a societal perspective. Quality-adjusted life years (QALYs) were derived from Veterans RAND 6-Dimension (VR-6D) and Short-Form 6-Dimension (SF-6D) single utility scores. Finally, we also simulated reducing the price for a 3-month app prescription to analyze at which price threshold DTC would result in being the dominant strategy over TAU in Germany. Results: The Monte Carlo simulation yielded on average a ?135.97 (a currency exchange rate of EUR ?1=US $1.069 is applicable) incremental cost and 0.004 incremental QALYs per person and year for the unsupervised DTC app strategy compared to in-person physiotherapy in Germany. The corresponding incremental cost-utility ratio (ICUR) amounts to an additional ?34,315.19 per additional QALY. DTC yielded more QALYs in 54.96% of the iterations. DTC dominates TAU in 24.04% of the iterations for QALYs. Reducing the app price in the simulation from currently ?239.96 to ?164.61 for a 3-month prescription could yield a negative ICUR and thus make DTC the dominant strategy, even though the estimated probability of DTC being more effective than TAU is only 54.96%. Conclusions: Decision-makers should be cautious when considering the reimbursement of DTC apps since no significant treatment effect was found, and the probability of cost-effectiveness remains below 60% even for an infinite willingness-to-pay threshold. More app-based studies involving the utilization of QoL outcome parameters are urgently needed to account for the low and limited precision of the available QoL input parameters, which are crucial to making profound recommendations concerning the cost-utility of novel apps. UR - https://mhealth.jmir.org/2023/1/e44585 UR - http://dx.doi.org/10.2196/44585 UR - http://www.ncbi.nlm.nih.gov/pubmed/37384379 ID - info:doi/10.2196/44585 ER - TY - JOUR AU - Merlot, Benjamin AU - Elie, Valéry AU - Périgord, Adrien AU - Husson, Zoé AU - Jubert, Amandine AU - Chanavaz-Lacheray, Isabella AU - Dennis, Thomas AU - Cotty-Eslous, Maryne AU - Roman, Horace PY - 2023/6/28 TI - Pain Reduction With an Immersive Digital Therapeutic in Women Living With Endometriosis-Related Pelvic Pain: At-Home Self-Administered Randomized Controlled Trial JO - J Med Internet Res SP - e47869 VL - 25 KW - randomized controlled trial KW - virtual reality KW - digital therapeutics KW - digital health KW - endometriosis KW - chronic pain KW - pelvic pain KW - women's health KW - digital health intervention KW - patient outcome N2 - Background: The management of chronic pelvic pain in women with endometriosis is complex and includes the long-term use of opioids. Patients not fully responsive to drugs or ineligible for surgical treatments need efficient alternatives to improve their quality of life and avoid long-term sequelae. Objective: This randomized controlled trial aimed to assess the effects of repeated at-home administrations of a 20-minute virtual reality (VR) solution (Endocare) compared with a sham condition on pain in women experiencing pelvic pain due to endometriosis. Methods: Patients were instructed to use the VR headsets twice daily for at least 2 days and for up to 5 days starting on their first day of painful periods. Pain perception was measured using a numerical scale (0-10) before and 60, 120, and 180 minutes after each treatment administration. General pain, stress, fatigue, medication intake, and quality of life were reported daily by patients. Results: A total of 102 patients with endometriosis were included in the final analysis (Endocare group: n=51, 50%; sham group: n=51, 50%). The mean age was 32.88 years (SD 6.96) and the mean pain intensity before treatment was 6.53 (SD 1.74) and 6.22 (SD 1.69) for the Endocare group and the sham control group, respectively (P=.48). Pain intensity decreased in both groups from day 1 to day 5 along with a decrease in medication use. Maximum pain intensity reduction of 51.58% (SD 35.33) occurred at day 2, 120 minutes after treatment for the Endocare group and of 27.37% (SD 27.23) at day 3, 180 minutes after treatment for the control group. Endocare was significantly superior to the sham on day 1 (120 minutes, P=.04; 180 minutes, P=.001), day 2 (0 minutes, P=.02; 60, 120, and 180 minutes, all P<.001), and day 3 (60 minutes, P=.01; 120 minutes, P=.005; 180 minutes, P=.001). Similarly, the mean perceived pain relief was significantly higher with Endocare on day 1 (120 and 180 minutes P=.004 and P=.001, respectively) and day 2 (60, 120, and 180 minutes P=.003, P=.004, and P=.007, respectively) compared to the control. No adverse event was reported. Conclusions: This study confirmed the effectiveness and safety of self-repeated administrations of a VR immersive treatment used at home while reducing overall pain medication intake in women diagnosed with endometriosis experiencing moderate-to-severe pelvic pain. Trial Registration: ClinicalTrials.gov NCT05172492; https://clinicaltrials.gov/ct2/show/NCT05172492 UR - https://www.jmir.org/2023/1/e47869 UR - http://dx.doi.org/10.2196/47869 UR - http://www.ncbi.nlm.nih.gov/pubmed/37260160 ID - info:doi/10.2196/47869 ER - TY - JOUR AU - Peterson, Gunnel AU - Peolsson, Anneli PY - 2023/6/20 TI - Efficacy of Neck-Specific Exercise With Internet Support Versus Neck-Specific Exercise at a Physiotherapy Clinic in Chronic Whiplash-Associated Disorders: Multicenter Randomized Controlled Noninferiority Trial JO - J Med Internet Res SP - e43888 VL - 25 KW - internet-based intervention KW - telerehabilitation KW - whiplash associated disorders KW - neck KW - whiplash KW - physiotherapy KW - physiotherapist KW - physical therapy KW - neck pain KW - exercise KW - chronic pain KW - digital health intervention KW - telehealth KW - rehabilitation KW - pain management KW - internet-based KW - telemedicine KW - digital health N2 - Background: Neck-specific exercises (NSE) supervised by a physiotherapist twice a week for 12 weeks have shown good results in chronic whiplash-associated disorders (WADs), but the effect of exercise delivered via the internet is unknown. Objective: This study examined whether NSE with internet support (NSEIT) and 4 physiotherapy sessions for 12 weeks were noninferior to the same exercises supervised by a physiotherapist twice a week for 12 weeks (NSE). Methods: In this multicenter randomized controlled noninferiority trial with masked assessors, we recruited adults aged 18-63 years with chronic WAD grade II (ie, neck pain and clinical musculoskeletal signs) or III (ie, grade II plus neurological signs). Outcomes were measured at baseline and at 3- and 15-month follow-ups. The primary outcome was change in neck-related disability, measured with the Neck Disability Index (NDI; 0%-100%), with higher percentages indicating greater disability. Secondary outcomes were neck and arm pain intensity (Visual Analog Scale [VAS]), physical function (Whiplash Disability Questionnaire [WDQ] and Patient-Specific Functional Scale [PSFS]), health-related quality of life (EQ-5D-3L and EQ VAS), and self-rated recovery (Global Rating Scale [GRS]). The analyses were conducted on an intention-to-treat basis and with the per-protocol approach as sensitivity analyses. Results: Between April 6, 2017, and September 15, 2020, 140 participants were randomly assigned to the NSEIT group (n=70) or the NSE group (n=70); 63 (90%) and 64 (91%), respectively, were followed up at 3 months, and 56 (80%) and 58 (83%), respectively, at 15 months. NSEIT demonstrated noninferiority to NSE in the primary outcome NDI, as the 1-sided 95% CI of the mean difference in change did not cross the specified noninferiority margin (7 percentage units). There were no significant between-group differences in change in NDI at the 3- or 15-month follow-up, with a mean difference of 1.4 (95% CI ?2.5 to 5.3) and 0.9 (95% CI ?3.6 to 5.3), respectively. In both groups, the NDI significantly decreased over time (NSEIT: mean change ?10.1, 95% CI ?13.7 to ?6.5, effect size=1.33; NSE: mean change ?9.3, 95% CI ?12.8 to ?5.7, effect size=1.19 at 15 months; P<.001). NSEIT was noninferior to NSE for most of the secondary outcomes except for neck pain intensity and EQ VAS, but post hoc analyses showed no differences between the groups. Similar results were seen in the per-protocol population. No serious adverse events were reported. Conclusions: NSEIT was noninferior to NSE in chronic WAD and required less physiotherapist time. NSEIT could be used as a treatment for patients with chronic WAD grades II and III. Trial Registration: ClinicalTrials.gov NCT03022812; https://clinicaltrials.gov/ct2/show/NCT03022812 UR - https://www.jmir.org/2023/1/e43888 UR - http://dx.doi.org/10.2196/43888 UR - http://www.ncbi.nlm.nih.gov/pubmed/37338972 ID - info:doi/10.2196/43888 ER - TY - JOUR AU - Norman-Nott, Nell AU - Hesam-Shariati, Negin AU - Wilks, R. Chelsey AU - Schroeder, Jessica AU - Suh, Jina AU - Briggs, E. Nancy AU - McAuley, H. James AU - Quidé, Yann AU - Gustin, M. Sylvia PY - 2023/6/7 TI - Internet-Delivered Dialectical Behavioral Therapy Skills Training for Chronic Pain: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e41890 VL - 12 KW - internet-delivered KW - dialectical behavioral therapy KW - chronic pain KW - emotion dysregulation KW - emotion-centric intervention KW - mobile phone N2 - Background: Emotion dysregulation is key to the development and maintenance of chronic pain, feeding into a cycle of worsening pain and disability. Dialectical behavioral therapy (DBT), an evidence-based treatment for complex transdiagnostic conditions presenting with high emotion dysregulation, may be beneficial to manage and mitigate the emotional and sensory aspects of chronic pain. Increasingly, DBT skills training as a key component of standard DBT is being delivered as a stand-alone intervention without concurrent therapy to help develop skills for effective emotion regulation. A previous repeated-measure single-case trial investigating a novel technologically driven DBT skills training, internet-delivered DBT skills training for chronic pain (iDBT-Pain), revealed promising findings to improve both emotion dysregulation and pain intensity. Objective: This randomized controlled trial aims to examine the efficacy of iDBT-Pain in comparison with treatment as usual to reduce emotion dysregulation (primary outcome) for individuals with chronic pain after 9 weeks and at the 21-week follow-up. The secondary outcomes include pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, posttraumatic stress, harm avoidance, social cognition, sleep quality, life satisfaction, and well-being. The trial also examines the acceptability of the iDBT-Pain intervention for future development and testing. Methods: A total of 48 people with chronic pain will be randomly assigned to 1 of 2 conditions: treatment and treatment as usual. Participants in the treatment condition will receive iDBT-Pain, consisting of 6 live web-based group sessions led by a DBT skills trainer and supervised by a registered psychologist and the iDBT-Pain app. Participants in the treatment-as-usual condition will not receive iDBT-Pain but will still access their usual medication and health interventions. We predict that iDBT-Pain will improve the primary outcome of emotion dysregulation and the secondary outcomes of pain intensity, pain interference, anxiety symptoms, depressive symptoms, perceived stress, harm avoidance, social cognition, sleep quality, life satisfaction, and well-being. A linear mixed model with random effects of individuals will be conducted to investigate the differences between the baseline, 9-week (primary end point), and 21-week (follow-up) assessments as a function of experimental condition. Results: Recruitment started in February 2023, and the clinical trial started in March 2023. Data collection for the final assessment is planned to be completed by July 2024. Conclusions: If our hypothesis is confirmed, our findings will contribute to the evidence for the efficacy and acceptability of a viable intervention that may be used by health care professionals for people with chronic pain. The results will add to the chronic pain literature to inform about the potential benefits of DBT skills training for chronic pain and will contribute evidence about technologically driven interventions. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12622000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383208&isReview=true International Registered Report Identifier (IRRID): PRR1-10.2196/41890 UR - https://www.researchprotocols.org/2023/1/e41890 UR - http://dx.doi.org/10.2196/41890 UR - http://www.ncbi.nlm.nih.gov/pubmed/37285187 ID - info:doi/10.2196/41890 ER - TY - JOUR AU - Dy, Marika AU - Olazo, Kristan AU - Lisker, Sarah AU - Brown, Ellenor AU - Saha, Anindita AU - Weinberg, Jessica AU - Sarkar, Urmimala PY - 2023/6/6 TI - Virtual Reality for Chronic Pain Management Among Historically Marginalized Populations: Systematic Review of Usability Studies JO - J Med Internet Res SP - e40044 VL - 25 KW - virtual reality KW - chronic pain management KW - systematic review KW - historically marginalized populations KW - VR KW - usability KW - pain management KW - pain KW - chronic pain N2 - Background: Virtual reality (VR) has potential to improve chronic pain management outcomes. However, the majority of studies assessing VR are conducted in predominantly White populations in well-resourced settings, thus leaving a gap in knowledge of VR use among diverse populations who experience a significant chronic pain burden. Objective: This review aims to examine the extent to which usability of VR for chronic pain management has been studied within historically marginalized patient groups. Methods: We conducted a systematic search to identify studies with usability outcomes located in high-income countries that included a historically marginalized population, defined by a mean age greater than or equal to 65 years, lower educational attainment (greater than or equal to 60% having attained high school education or less), and being a racial or ethnic minority (less than or equal to 50% non-Hispanic White people for studies based in the United States). Results: Our analysis included 5 papers, which we used to conduct a narrative analysis. Three studies examined VR usability as a primary outcome. All studies assessed VR usability using different measures, of which 4 found VR to be usable by their respective study population. Only 1 study found a significant improvement in pain levels post?VR intervention. Conclusions: The use of VR shows promise for chronic pain management, but few studies include populations that are older, have limited educational attainment, or have racial or ethnic diversity. Additional studies with these populations are needed to further develop VR systems that work best for diverse patients with chronic pain. UR - https://www.jmir.org/2023/1/e40044 UR - http://dx.doi.org/10.2196/40044 UR - http://www.ncbi.nlm.nih.gov/pubmed/37279039 ID - info:doi/10.2196/40044 ER - TY - JOUR AU - Shade, Marcia AU - Kovaleva, Mariya AU - Harp, Kimberly AU - Martin-Hammond, Aqueasha PY - 2023/5/31 TI - Older Adults? Pain Outcomes After mHealth Interventions: Scoping Review JO - JMIR Aging SP - e46976 VL - 6 KW - mHealth KW - older adults KW - pain KW - self-management KW - pain management KW - mobile health KW - musculoskeletal pain KW - scoping review KW - pain outcomes KW - mobile phone N2 - Background: Pain is prevalent and poorly managed in older adults. Although pain self-management strategies are helpful, adoption and access are limited; thus, technology provides an opportunity for intervention delivery. Mobile health (mHealth) is feasible to use in older adults; however, we have yet to understand the effect of mHealth pain self-management interventions on pain outcomes in older adults. Objective: The purpose of this scoping review is to examine the characteristics of mHealth interventions and their efficacy on pain outcomes in older adults with musculoskeletal pain. Methods: With the assistance of a medical librarian, keywords and subject headings were generated, including but not limited to mobile health application, mHealth, digital, pain, pain management, and older. A search was conducted for papers in journal databases, including PubMed, Embase, CINAHL, Scopus, and IEEE Xplore, between 2000 and 2022. Papers were screened according to predetermined inclusion and exclusion criteria, and reference lists were reviewed for additional paper inclusion. Three authors appraised the methodology of papers independently, then collaboratively to synthesize the evidence. Results: Six publications were included in the scoping review. The design and methodology ranged widely from pilot studies to a comparative effectiveness trial. Older participants in the studies reported a variety of musculoskeletal conditions. Delivery of the mHealth pain self-management interventions incorporated mobile devices, such as a smartphone or tablet. Most mHealth-delivered interventions were multicomponent and incorporated elements of in-person and telephone access to an interventionist. The findings suggested mHealth interventions may reduce pain intensity; however, pain interference and other pain-related conditions did not have a statistically significant reduction. Conclusions: Research that has explored mHealth for pain self-management is beginning to move beyond feasibility. The few experimental studies conducted in older adults are heterogeneous, and the interventions are mostly multicomponent. It is premature to conclude the interventions? significant effect on pain or pain-related symptoms. As technology continues to integrate into health care, more experimental research is warranted to examine the efficacy of mHealth interventions on a variety of pain outcomes in older adults. UR - https://aging.jmir.org/2023/1/e46976 UR - http://dx.doi.org/10.2196/46976 UR - http://www.ncbi.nlm.nih.gov/pubmed/37256667 ID - info:doi/10.2196/46976 ER - TY - JOUR AU - Johansen, Kristoffer Simon AU - Kanstrup, Marie Anne AU - Haseli, Kian AU - Stenmo, Hildebrandt Visti AU - Thomsen, Laust Janus AU - Rathleff, Skovdal Michael PY - 2023/4/28 TI - Exploring User Visions for Modeling mHealth Apps Toward Supporting Patient-Parent-Clinician Collaboration and Shared Decision-making When Treating Adolescent Knee Pain in General Practice: Workshop Study JO - JMIR Hum Factors SP - e44462 VL - 10 KW - mobile health KW - mHealth KW - design KW - patient physician relationship KW - collaborative care KW - shared decision-making KW - adolescents KW - parents KW - knee pain KW - patellofemoral pain KW - Osgood Schlatter KW - musculoskeletal KW - general practice KW - primary care KW - mobile phone N2 - Background: Long-standing knee pain is one of the most common reasons for adolescents (aged 10-19 years) to consult general practice. Generally, 1 in 2 adolescents will continue to experience pain after 2 years, but exercises and self-management education can improve the prognosis. However, adherence to exercises and self-management education interventions remains poor. Mobile health (mHealth) apps have the potential for supporting adolescents? self-management, enhancing treatment adherence, and fostering patient-centered approaches. However, it remains unclear how mHealth apps should be designed to act as tools for supporting individual and collaborative management of adolescents? knee pain in a general practice setting. Objective: The aim of the study was to extract design principles for designing mHealth core features, which were both sufficiently robust to support adolescents? everyday management of their knee pain and sufficiently flexible to act as enablers for enhancing patient-parent collaboration and shared decision-making. Methods: Overall, 3 future workshops were conducted with young adults with chronic knee pain since adolescence, parents, and general practitioners (GPs). Each workshop followed similar procedures, using case vignettes and design cards to stimulate discussions, shared construction of knowledge and elicit visions for mHealth designs. Young adults and parents were recruited via social media posts targeting individuals in Northern Jutland. GPs were recruited via email and cold calling. Data were transcribed and analyzed thematically using NVivo (QSR International) coding software. Extracted themes were synthesized in a matrix to map tensions in the collaborative space and inform a conceptual model for designing mHealth core-features to support individual and collaborative management of knee pain. Results: Overall, 38% (9/24) young adults with chronic knee pain since adolescence, 25% (6/24) parents, and 38% (9/24) GPs participated in the workshops. Data analysis revealed how adolescents, parents, and clinicians took on different roles within the collaborative space, with different tasks, challenges, and information needs. In total, 5 themes were identified: adolescents as explorers of pain and social rules; parents as supporters, advocates and enforcers of boundaries; and GPs as guides, gatekeepers, and navigators or systemic constraints described participants? roles; collaborative barriers and tensions referred to the contextual elements; and visions for an mHealth app identified beneficial core features. The synthesis informed a conceptual model, outlining 3 principles for consolidating mHealth core features as enablers for supporting role negotiation, limiting collaborative tensions, and facilitating shared decision-making. Conclusions: An mHealth app for treating adolescents with knee pain should be designed to accommodate multiple users, enable them to shift between individual management decision-making, take charge, and engage in role negotiation to inform shared decision-making. We identified 3 silver-bullet principles for consolidating mHealth core features as enablers for negotiation by supporting patient-GP collaboration, supporting transitions, and cultivating the parent-GP alliance. UR - https://humanfactors.jmir.org/2023/1/e44462 UR - http://dx.doi.org/10.2196/44462 UR - http://www.ncbi.nlm.nih.gov/pubmed/37115609 ID - info:doi/10.2196/44462 ER - TY - JOUR AU - Li, Lili AU - Wu, Sicheng AU - Wang, Jian AU - Wang, Chunchun AU - Zuo, Weixin AU - Yu, Liping AU - Song, Jiangang PY - 2023/4/17 TI - Development of the Emoji Faces Pain Scale and Its Validation on Mobile Devices in Adult Surgery Patients: Longitudinal Observational Study JO - J Med Internet Res SP - e41189 VL - 25 KW - pain KW - mHealth KW - scale development KW - emoji KW - surgery N2 - Background: Measuring pain on digital devices using classic unidimensional pain scales such as the visual analog scale (VAS), numerical rating scale (NRS), and faces pain scale (FPS) has been proven to be reliable and valid. Emoji are pictographs designed in colorful form following the Unicode standard. It could be more beneficial to use emoji as faces of FPS on digital devices because emoji can easily fit on most devices and emoji are open-source so no approval would be needed before use. With a concise and user-friendly design, the emoji faces pain scale (Emoji-FPS) might be more generalizable to a wider population and more preferred by digital device users. Objective: This study was designed to develop an Emoji-FPS as well as to evaluate its reliability, validity, and preference on mobile devices in adult patients who underwent surgery. Methods: A modified Delphi technique with 2 rounds of web-based surveys was applied to obtain panelists? consensus on the sequence of emoji that can best represent 6 levels of pain. The initial candidate sequences of emoji for the Delphi process were constructed referring to 2 well-validated FPSs (Wong-Baker FACES pain rating scale [Wong-Baker FACES] and faces pain scale-revised [FPS-R]). Then, a prospective cohort of patients scheduled to receive perianal surgery was recruited and asked to complete a web-based questionnaire on a mobile device at 5 time points (before surgery [T1], wake up after surgery [T2], 4 hours after surgery [T3], the second day after surgery [T4], and 15 minutes after T4 [T5]). The 4 well-validated pain scales (NRS, VAS, Wong-Baker FACES, and FPS-R) were used as reference scales. Results: After 2 rounds of surveys on 40 Delphi panelists, an Emoji-FPS was finally determined to represent 6 pain levels (0, 2, 4, 6, 8, and 10) from ?no hurt? to ?hurts worst.? For validation, 300 patients were recruited and 299 were analyzed, the mean age of whom was 38.5 (SD 10.5) years, and 106 (35.5%) were women. For concurrent validity, the Emoji-FPS was highly correlated with 4 reference scales with Spearman correlation coefficient ? ranging from 0.91 to 0.95. Excellent agreements were observed between 4 versions of Emoji-FPS (iOS, Android, Microsoft, and OpenMoji), with weighted ? coefficients ranging from 0.96 to 0.97. For discriminant validity, patients? mean preoperative Emoji-FPS score (T1) was significantly higher than their postoperative Emoji-FPS score (T4) with a difference of 1.4 (95% CI 1.3-1.6; P<.001). For test-retest reliability, Emoji-FPS scores measured at T4 and T5 were highly correlated with a ? of 0.91. The Emoji-FPS was mostly preferred, followed by the Wong-Baker FACES, FPS-R, NRS, and VAS. Conclusions: The Emoji-FPS is reliable and valid compared with traditional pain scales in adult surgery patients. UR - https://www.jmir.org/2023/1/e41189 UR - http://dx.doi.org/10.2196/41189 UR - http://www.ncbi.nlm.nih.gov/pubmed/37067854 ID - info:doi/10.2196/41189 ER - TY - JOUR AU - Guo, Qifan AU - Zhang, LIMing AU - Gui, Chenfan AU - Chen, Guanghui AU - Chen, Yi AU - Tan, Huixin AU - Su, Wei AU - Zhang, Ruishi AU - Gao, Qiang PY - 2023/4/3 TI - Virtual Reality Intervention for Patients With Neck Pain: Systematic Review and Meta-analysis of Randomized Controlled Trials JO - J Med Internet Res SP - e38256 VL - 25 KW - meta-analysis KW - virtual reality KW - neck pain KW - disability KW - systematic review N2 - Background: Neck pain is a prevalent condition that causes an enormous health care burden due to the lack of efficient therapies. As a promising technology, virtual reality (VR) has shown advantages in orthopedic rehabilitation. However, there is no meta-analysis evaluating the effectiveness of VR in neck pain management. Objective: This study aims to review original randomized controlled trials (RCTs) evaluating the effectiveness of VR for neck pain and to provide evidence for the clinical application of a new alternative approach for pain management. Methods: A total of 9 electronic databases were systematically searched for relevant articles published from inception to October 2022. RCTs in English or Chinese that investigated VR therapy for participants with neck pain were included. The methodological quality and the evidence level were assessed using the Cochrane Back and Neck Risk of Bias tool and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) guideline, respectively. Results: A total of 8 studies with 382 participants were included for the final analysis. For the pain intensity, the overall pooled effect size was 0.51, with a standardized mean difference (SMD) of ?0.51 (95% CI ?0.91 to ?0.11; GRADE: moderate), favoring VR therapy compared with controls. Subgroups analyses revealed that significant differences in pain intensity were found in the multimodal intervention (VR in combination with other therapies) than in other interventions (SMD ?0.45, 95% CI ?0.78 to ?0.13; GRADE: moderate), and better analgesic effects were also observed in patients with chronic neck pain receiving VR intervention (SMD ?0.70, 95% CI ?1.08 to ?0.32; GRADE: moderate) and patients treated in the clinic or research unit (SMD ?0.52, 95% CI ?0.99 to ?0.05; GRADE: moderate) than controls. Regarding other health outcomes, the VR experienced less disability, lower kinesiophobia, and greater kinematic function (cervical range of motion, mean and peak velocity). Nevertheless, the follow-up effects of VR therapy on pain intensity and disability were not found. Conclusions: Existing moderate evidence support VR as a beneficial nonpharmacological approach to improve pain intensity in patients with neck pain, with advantages to multimodal intervention, people with chronic neck pain, and clinic or research unit?based VR therapy. However, the limited quantity and high heterogeneity of the articles limit our findings. Trial Registration: PROSPERO CRD42020188635; https://tinyurl.com/2839jh8w UR - https://www.jmir.org/2023/1/e38256 UR - http://dx.doi.org/10.2196/38256 UR - http://www.ncbi.nlm.nih.gov/pubmed/37010891 ID - info:doi/10.2196/38256 ER - TY - JOUR AU - Newman, Christie AU - Adriaens, Els AU - Virgilio, Nicolina AU - Vleminckx, Sara AU - de Pelsmaeker, Sara AU - Prawitt, Janne AU - F Silva, I. Catarina PY - 2023/4/3 TI - Development of a Mobile App to Monitor the Effectiveness of a Hydrolyzed Cartilage Matrix Supplement on Joint Discomfort: Real-World Study JO - JMIR Form Res SP - e42967 VL - 7 KW - digital tool KW - hydrolyzed cartilage matrix KW - hydrolyzed collagen KW - chondroitin sulfate KW - joint discomfort KW - real-world study KW - dietary supplement KW - mobile application N2 - Background: Joint discomfort is a widespread and growing problem in active adults. The rising interest in preventative nutrition has increased the demand for supplements reducing joint discomfort. Protocols assessing the effect of a nutritional intervention on health commonly involve a series of face-to-face meetings between participants and study staff that can weigh on resources, participant availabilities, and even increase dropout rates. Digital tools are increasingly added to protocols to facilitate study conduct, but fully digitally run studies are still scarce. With the increasing interest in real-world studies, the development of health apps for mobile devices to monitor study outcomes is of great importance. Objective: The purpose of this real-world study was to develop a specific mobile app, Ingredients for Life, to conduct a 100% digital study testing the effectiveness of a hydrolyzed cartilage matrix (HCM) supplement on joint discomfort in a heterogeneous group of healthy, active consumers. Methods: The Ingredients for Life mobile app using a visual analog scale was specifically developed to monitor the variation in joint pain after exercise by the study participants. A total of 201 healthy and physically active women and men (18-72 years old) with joint pain completed the study over a period of 16 weeks. Participants were randomly allocated to the study groups and did not receive any dietary or lifestyle advice. Each participant indicated one area of joint pain and logged the type and duration of their weekly activities. They received blinded study supplements and took a daily regimen of 1 g of HCM (HCM group) or 1 g of maltodextrin (placebo group) for 12 weeks while weekly logging joint pain scores in the app. This was followed by a 4-week washout period during which participants continued reporting their joint pain scores (until the end of week 16). Results: Joint pain was reduced within 3 weeks of taking a low dosage of HCM (1 g/day), regardless of gender, age group, and activity intensity when compared with the placebo group. After stopping supplementation, joint pain scores gradually increased but still remained significantly lower than those of the placebo group after 4 weeks of washout. The low dropout rate (<6% of participants, mainly in the placebo group) demonstrates that the digital study was well received by the study population. Conclusions: The digital tool allowed us to measure a heterogeneous group of active adults in a real-world setting (without any lifestyle intervention), thus promoting inclusivity and diversity. With low dropout rates, it demonstrates that mobile apps can generate qualitative, quantifiable, real-world data showcasing supplement effectiveness. The study confirmed that the oral intake of a low dose (1 g/day) of HCM led to a significant reduction of joint pain from 3 weeks after starting supplementation. UR - https://formative.jmir.org/2023/1/e42967 UR - http://dx.doi.org/10.2196/42967 UR - http://www.ncbi.nlm.nih.gov/pubmed/36848035 ID - info:doi/10.2196/42967 ER - TY - JOUR AU - Howard, Fuchsia A. AU - Noga, Heather AU - Parmar, Gurkiran AU - Kennedy, Lan AU - Aragones, Sarah AU - Bassra, Roop AU - Gelfer, Lauren AU - Lopez de Arbina, Edurne AU - Sutherland, Jessica AU - Allaire, Catherine AU - Oliffe, L. John AU - Currie, M. Leanne AU - Yager, Holly AU - Yong, J. Paul PY - 2023/3/14 TI - Web-Based Digital Storytelling for Endometriosis and Pain: Qualitative Pilot Study JO - JMIR Form Res SP - e37549 VL - 7 KW - digital storytelling KW - endometriosis KW - pain KW - chronic pain KW - painful sex KW - dyspareunia KW - integrated knowledge translation KW - patient-oriented research KW - community-based participatory research KW - qualitative research KW - arts-based research KW - group therapy KW - sex therapy N2 - Background: Endometriosis is a complex chronic disease characterized by pain, including painful sex, that can contribute to considerable sexual function, self-esteem, and relationship challenges. Digital storytelling is an arts-based, participatory methodology wherein individuals create and share their illness experiences in detailing their lived experiences. Objective: The study objective was to pilot-test a web-based digital storytelling workshop focused on endometriosis to understand storytellers? experiences of workshop participation. We assessed the feasibility of story cocreation and sharing, including the emotional impact of workshop participation, the acceptability of the workshop for the subject matter, and the storytellers? willingness to share their stories with broader audiences as a method for knowledge translation. Methods: This study used a community-based participatory methodology supplemented with patient-oriented research and integrated knowledge translation. Study participants, referred to as storytellers, cocreated 3- to 5-minute individual digital stories about their lived experiences of endometriosis during a web-based workshop (comprising five 2-hour sessions over 6 weeks) facilitated by The Center for Digital Storytelling. Data were collected through participant observations at the workshop, storyteller weekly reflective journals, and an end-of-workshop focus group interview with storytellers. These data were analyzed using a qualitative interpretive description approach. Results: A total of 5 women and 1 nonbinary storyteller aged 19 to 39 years who had experienced endometriosis for 4 to 22 years participated in the study. We characterized storytelling workshop participation and the acceptability of story cocreation by describing participants? experiences of opportunity, commitment, and connection; complex emotions that were healing; and a desire to share. Feasibility was demonstrated through 100% engagement in the workshops. All 6 storytellers reported feeling empowered by publicly sharing their cocreated digital stories through social media and the Sex, Pain & Endometriosis website. Conclusions: Despite the complexities of the story-building process, the workshop and the cocreation and sharing of digital stories were feasible. The storytellers found that this process allowed for emotional healing and personal empowerment by offering a unique way to talk about painful sex, which also facilitated a connection among those in the workshop. The use of digital storytelling as a knowledge translation tool shows promise, and this approach also has potential as a therapeutic intervention. UR - https://formative.jmir.org/2023/1/e37549 UR - http://dx.doi.org/10.2196/37549 UR - http://www.ncbi.nlm.nih.gov/pubmed/36917164 ID - info:doi/10.2196/37549 ER - TY - JOUR AU - Teepe, Wilhelm Gisbert AU - Kowatsch, Tobias AU - Hans, Patricius Felix AU - Benning, Leo PY - 2023/2/27 TI - Postmarketing Follow-Up of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time-Series and Matched-Pair Analysis JO - J Med Internet Res SP - e43775 VL - 25 KW - digital therapeutics KW - digital health KW - musculoskeletal diseases KW - exercise training N2 - Background: Musculoskeletal conditions are the main drivers of global disease burden and cause significant direct and indirect health care costs. Digital health applications improve the availability of and access to adequate care. The German health care system established a pathway for the approval of ?Digitale Gesundheitsanwendungen? (DiGAs; Digital Health Applications) as collectively funded medical services through the ?Digitale-Versorgung-Gesetz? (Digital Health Care Act) in 2019. Objective: This article presents real-world prescription data collected through the smartphone-based home exercise program ?Vivira,? a fully approved DiGA, regarding its effect on self-reported pain intensity and physical inability in patients with unspecific and degenerative pain in the back, hip, and knee. Methods: This study included 3629 patients (71.8% [2607/3629] female; mean age 47 years, SD 14.2 years). The primary outcome was the self-reported pain score, which was assessed with a verbal numerical rating scale. The secondary outcomes were self-reported function scores. To analyze the primary outcome, we used a 2-sided Skillings-Mack test. For function scores, a time analysis was not feasible; therefore, we calculated matched pairs using the Wilcoxon signed-rank test. Results: Our results showed significant reductions in self-reported pain intensity after 2, 4, 8, and 12 weeks in the Skillings-Mack test (T3628=5308; P<.001). The changes were within the range of a clinically relevant improvement. Function scores showed a generally positive yet more variable response across the pain areas (back, hip, and knee). Conclusions: This study presents postmarketing observational data from one of the first DiGAs for unspecific and degenerative musculoskeletal pain. We noted significant improvements in self-reported pain intensity throughout the observation period of 12 weeks, which reached clinical relevance. Additionally, we identified a complex response pattern of the function scores assessed. Lastly, we highlighted the challenges of relevant attrition at follow-up and the potential opportunities for evaluating digital health applications. Although our findings do not have confirmatory power, they illustrate the potential benefits of digital health applications to improve the availability of and access to medical care. Trial Registration: German Clinical Trials Register DRKS00024051; https://drks.de/search/en/trial/DRKS00024051 UR - https://www.jmir.org/2023/1/e43775 UR - http://dx.doi.org/10.2196/43775 UR - http://www.ncbi.nlm.nih.gov/pubmed/36848211 ID - info:doi/10.2196/43775 ER - TY - JOUR AU - Hughes, David Jeffery AU - Chivers, Paola AU - Hoti, Kreshnik PY - 2023/2/13 TI - The Clinical Suitability of an Artificial Intelligence?Enabled Pain Assessment Tool for Use in Infants: Feasibility and Usability Evaluation Study JO - J Med Internet Res SP - e41992 VL - 25 KW - pain assessment KW - clinical utility KW - sensitivity KW - specificity KW - immunization KW - accuracy KW - precision KW - PainChek Infant KW - infant KW - newborn KW - baby KW - babies KW - pain KW - facial KW - artificial intelligence KW - machine learning KW - model KW - detection KW - assessment N2 - Background: Infants are unable to self-report their pain, which, therefore, often goes underrecognized and undertreated. Adequate assessment of pain, including procedural pain, which has short- and long-term consequences, is critical for its management. The introduction of mobile health?based (mHealth) pain assessment tools could address current challenges and is an area requiring further research. Objective: The purpose of this study is to evaluate the accuracy and feasibility aspects of PainChek Infant and, therefore, assess its applicability in the intended setting. Methods: By observing infants just before, during, and after immunization, we evaluated the accuracy and precision at different cutoff scores of PainChek Infant, which is a point-of-care mHealth?based solution that uses artificial intelligence to detect pain and intensity based solely on facial expression. We used receiver operator characteristic analysis to assess interpretability and establish a cutoff score. Clinician comprehensibility was evaluated using a standardized questionnaire. Other feasibility aspects were evaluated based on comparison with currently available observational pain assessment tools for use in infants with procedural pain. Results: Both PainChek Infant Standard and Adaptive modes demonstrated high accuracy (area under the curve 0.964 and 0.966, respectively). At a cutoff score of ?2, accuracy and precision were 0.908 and 0.912 for Standard and 0.912 and 0.897 for Adaptive modes, respectively. Currently available data allowed evaluation of 16 of the 17 feasibility aspects, with only the cost of the outcome measurement instrument unable to be evaluated since it is yet to be determined. PainChek Infant performed well across feasibility aspects, including interpretability (cutoff score defined), ease of administration, completion time (3 seconds), and clinician comprehensibility. Conclusions: This work provides information on the feasibility of using PainChek Infant in clinical practice for procedural pain assessment and monitoring, and demonstrates the accuracy and precision of the tool at the defined cutoff score. UR - https://www.jmir.org/2023/1/e41992 UR - http://dx.doi.org/10.2196/41992 UR - http://www.ncbi.nlm.nih.gov/pubmed/36780223 ID - info:doi/10.2196/41992 ER - TY - JOUR AU - Ali, Mustafa Syed AU - Lee, R. Rebecca AU - McBeth, John AU - James, Ben AU - McAlister, Sean AU - Chiarotto, Alessandro AU - Dixon, G. William AU - van der Veer, N. Sabine PY - 2023/2/8 TI - Exploring the Cross-cultural Acceptability of Digital Tools for Pain Self-reporting: Qualitative Study JO - JMIR Hum Factors SP - e42177 VL - 10 KW - chronic pain KW - pain perception KW - cross-cultural comparison KW - pain measurement KW - mobile app KW - mobile phone N2 - Background: Culture and ethnicity influence how people communicate about their pain. This makes it challenging to develop pain self-report tools that are acceptable across ethnic groups. Objective: We aimed to inform the development of cross-culturally acceptable digital pain self-report tools by better understanding the similarities and differences between ethnic groups in pain experiences and self-reporting needs. Methods: Three web-based workshops consisting of a focus group and a user requirement exercise with people who self-identified as being of Black African (n=6), South Asian (n=10), or White British (n=7) ethnicity were conducted. Results: Across ethnic groups, participants shared similar lived experiences and challenges in communicating their pain to health care professionals. However, there were differences in beliefs about the causes of pain, attitudes toward pain medication, and experiences of how stigma and gender norms influenced pain-reporting behavior. Despite these differences, they agreed on important aspects for pain self-report, but participants from non-White backgrounds had additional language requirements such as culturally appropriate pain terminologies to reduce self-reporting barriers. Conclusions: To improve the cross-cultural acceptability and equity of digital pain self-report tools, future developments should address the differences among ethnic groups on pain perceptions and beliefs, factors influencing pain reporting behavior, and language requirements. UR - https://humanfactors.jmir.org/2023/1/e42177 UR - http://dx.doi.org/10.2196/42177 UR - http://www.ncbi.nlm.nih.gov/pubmed/36753324 ID - info:doi/10.2196/42177 ER - TY - JOUR AU - Moreno-Ligero, Marta AU - Moral-Munoz, A. Jose AU - Salazar, Alejandro AU - Failde, Inmaculada PY - 2023/2/2 TI - mHealth Intervention for Improving Pain, Quality of Life, and Functional Disability in Patients With Chronic Pain: Systematic Review JO - JMIR Mhealth Uhealth SP - e40844 VL - 11 KW - chronic pain KW - mHealth KW - mobile health KW - mobile app KW - health app KW - digital intervention KW - monitoring KW - pain intensity KW - quality of life KW - functionality KW - disability KW - disabilities KW - systematic review KW - review methodology KW - search strategy KW - library science KW - RCT KW - randomized controlled trial KW - pain KW - health outcome KW - self-management N2 - Background: Chronic pain (CP) is 1 of the leading causes of disability worldwide and represents a significant burden on individual, social, and economic aspects. Potential tools, such as mobile health (mHealth) systems, are emerging for the self-management of patients with CP. Objective: A systematic review was conducted to analyze the effects of mHealth interventions on CP management, based on pain intensity, quality of life (QoL), and functional disability assessment, compared to conventional treatment or nonintervention. Methods: PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines were followed to conduct a systematic review of randomized controlled trials (RCTs) published in PubMed, Web of Science, Scopus, and Physiotherapy Evidence Database (PEDro) databases from February to March 2022. No filters were used. The eligibility criteria were RCTs of adults (?18 years old) with CP, intervened with mHealth systems based on mobile apps for monitoring pain and health-related outcomes, for pain and behavioral self-management, and for performing therapeutic approaches, compared to conventional treatments (physical, occupational, and psychological therapies; usual medical care; and education) or nonintervention, reporting pain intensity, QoL, and functional disability. The methodological quality and risk of bias (RoB) were assessed using the Checklist for Measuring Quality, the Oxford Centre for Evidence-Based Medicine Levels of Evidence, and the Cochrane RoB 2.0 tool. Results: In total, 22 RCTs, involving 2641 patients with different CP conditions listed in the International Classification of Diseases 11th Revision (ICD-11), including chronic low back pain (CLBP), chronic musculoskeletal pain (CMSP), chronic neck pain (CNP), unspecified CP, chronic pelvic pain (CPP), fibromyalgia (FM), interstitial cystitis/bladder pain syndrome (IC/BPS), irritable bowel syndrome (IBS), and osteoarthritis (OA). A total of 23 mHealth systems were used to conduct a variety of CP self-management strategies, among which monitoring pain and symptoms and home-based exercise programs were the most used. Beneficial effects of the use of mHealth systems in reducing pain intensity (CNP, FM, IC/BPS, and OA), QoL (CLBP, CNP, IBS, and OA), and functional disability (CLBP, CMSP, CNP, and OA) were found. Most of the included studies (18/22, 82%) reported medium methodological quality and were considered as highly recommendable; in addition, 7/22 (32%) studies had a low RoB, 10/22 (45%) had some concerns, and 5/22 (23%) had a high RoB. Conclusions: The use of mHealth systems indicated positive effects for pain intensity in CNP, FM, IC/BPS, and OA; for QoL in CLBP, CNP, IBS, and OA; and for functional disability in CLBP, CMSP, CNP, and OA. Thus, mHealth seems to be an alternative to improving pain-related outcomes and QoL and could be part of multimodal strategies for CP self-management. High-quality studies are needed to merge the evidence and recommendations of the use of mHealth systems for CP management. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42022315808; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=315808 UR - https://mhealth.jmir.org/2023/1/e40844 UR - http://dx.doi.org/10.2196/40844 UR - http://www.ncbi.nlm.nih.gov/pubmed/36729570 ID - info:doi/10.2196/40844 ER - TY - JOUR AU - Teepe, Wilhelm Gisbert AU - Kowatsch, Tobias AU - Hans, Patricius Felix AU - Benning, Leo PY - 2022/12/2 TI - Preliminary Use and Outcome Data of a Digital Home Exercise Program for Back, Hip, and Knee Pain: Retrospective Observational Study With a Time Series and Matched Analysis JO - JMIR Mhealth Uhealth SP - e38649 VL - 10 IS - 12 KW - digital health KW - home exercise KW - musculoskeletal conditions KW - digital intervention KW - exercise KW - physical activity KW - smartphone KW - pain KW - management KW - back pain KW - hip pain KW - knee pain KW - mobility KW - intervention N2 - Background: Musculoskeletal conditions are among the main contributors to the global burden of disease. International guidelines consider patient education and movement exercises as the preferred therapeutic option for unspecific and degenerative musculoskeletal conditions. Innovative and decentralized therapeutic means are required to provide access to and availability of such care to meet the increasing therapeutic demand for this spectrum of conditions. Objective: This retrospective observational study of preliminary use and outcome data explores the clinical outcomes of Vivira (hereafter referred to as ?program?), a smartphone-based program for unspecific and degenerative pain in the back, hip, and knee before it received regulatory approval for use in the German statutory health insurance system. Methods: An incomplete matched block design was employed to assess pain score changes over the intended 12-week duration of the program. Post hoc analyses were performed. In addition, a matched comparison of self-reported functional scores and adherence rates is presented. Results: A total of 2517 participants met the inclusion criteria and provided sufficient data to be included in the analyses. Overall, initial self-reported pain scores decreased significantly from an average of 5.19 out of 10 (SD 1.96) to an average of 3.35 out of 10 (SD 2.38) after 12 weeks. Post hoc analyses indicate a particularly emphasized pain score reduction over the early use phases. Additionally, participants with back pain showed significant improvements in strength and mobility scores, whereas participants with hip or knee pain demonstrated significant improvements in their coordination scores. Across all pain areas and pain durations, a high yet expected attrition rate could be observed. Conclusions: This observational study provides the first insights into the clinical outcomes of an exercise program for unspecific and degenerative back, hip, and knee pain. Furthermore, it demonstrates a potential secondary benefit of improved functionality (ie, strength, mobility, coordination). However, as this study lacks confirmatory power, further research is required to substantiate the clinical outcomes of the program assessed. Trial Registration: German Clinical Trials Register DRKS00021785; https://drks.de/search/en/trial/DRKS00021785 UR - https://mhealth.jmir.org/2022/12/e38649 UR - http://dx.doi.org/10.2196/38649 UR - http://www.ncbi.nlm.nih.gov/pubmed/36459399 ID - info:doi/10.2196/38649 ER - TY - JOUR AU - Maarj, Muhammad AU - Pacey, Verity AU - Tofts, Louise AU - Clapham, Matthew AU - Gironès Garcia, Xavier AU - Coda, Andrea PY - 2022/10/26 TI - Validation of an Electronic Visual Analog Scale App for Pain Evaluation in Children and Adolescents With Symptomatic Hypermobility: Cross-sectional Study JO - JMIR Pediatr Parent SP - e41930 VL - 5 IS - 4 KW - hypermobility syndrome KW - Ehlers-Danlos syndrome KW - hypermobility KW - hypermobile KW - mobile application KW - mobile app KW - pain measurement KW - pain KW - validation KW - validate KW - scale KW - measure KW - pain severity KW - pediatric KW - visual analogue scale KW - mHealth KW - mobile health KW - children KW - adolescent KW - youth KW - child KW - digital health tool N2 - Background: Rapid advances in mobile apps for clinical data collection for pain evaluation have resulted in more efficient data handling and analysis than traditional paper-based approaches. As paper-based visual analogue scale (p-VAS) scores are commonly used to assess pain levels, new emerging apps need to be validated prior to clinical application with symptomatic children and adolescents. Objective: This study aimed to assess the validity and reliability of an electronic visual analogue scale (e-VAS) method via a mobile health (mHealth) App in children and adolescents diagnosed with hypermobility spectrum disorder/hypermobile Ehlers-Danlos syndrome (HSD/HEDS) in comparison with the traditional p-VAS. Methods: Children diagnosed with HSD/HEDS aged 5-18 years were recruited from a sports medicine center in Sydney (New South Wales, Australia). Consenting participants assigned in random order to the e-VAS and p-VAS platforms were asked to indicate their current lower limb pain level and completed pain assessment e-VAS or p-VAS at one time point. Instrument agreement between the 2 methods was determined from the intraclass correlation coefficient (ICC) and through Bland?Altman analysis. Results: In total, 43 children with HSD/HEDS aged 11 (SD 3.8) years were recruited and completed this study. The difference between the 2 VAS platforms of median values was 0.20. Bland?Altman analysis revealed a difference of 0.19 (SD 0.95) with limits of agreement ranging ?1.67 to 2.04. An ICC of 0.87 (95% CI 0.78-0.93) indicated good reliability. Conclusions: These findings suggest that the e-VAS mHealth App is a validated tool and a feasible method of collecting pain recording scores when compared with the traditional paper format in children and adolescents with HSD/HEDS. The e-VAS App can be reliably used for pediatric pain evaluation, and it could potentially be introduced into daily clinical practice to improve real-time symptom monitoring. Further research is warranted to investigate the usage of the app for remote support in real clinical settings. UR - https://pediatrics.jmir.org/2022/4/e41930 UR - http://dx.doi.org/10.2196/41930 UR - http://www.ncbi.nlm.nih.gov/pubmed/36287606 ID - info:doi/10.2196/41930 ER - TY - JOUR AU - Compère, Vincent AU - Mauger, Alban AU - Allard, Etienne AU - Clavier, Thomas AU - Selim, Jean AU - Besnier, Emmanuel PY - 2022/10/25 TI - Incidence of Postoperative Pain at 7 Days After Day Surgery Reported Using a Text Messaging Platform: Retrospective Observational Study JO - JMIR Perioper Med SP - e33276 VL - 5 IS - 1 KW - day surgery KW - postoperative pain KW - emergency consultation KW - rehospitalization KW - ambulatory management KW - pain management KW - postsurgery KW - postoperative KW - ambulatory surgery KW - hospitalization KW - health care KW - mobile health KW - mobile platform N2 - Background: The most frequent complication observed after ambulatory surgery is acute postoperative pain. Objective: The purpose of this study was to evaluate the late incidence of postoperative pain at 7 days after day surgery. Methods: We retrospectively included patients who underwent day surgery under general or regional anesthesia and those who underwent local anesthesia in Rouen University Hospital from January 2018 to February 2020. Data collected were moderate-to-severe pain reports defined as numeric rating scale (NRS)>3/10 at 1 day (secondary end point) and 7 days (primary end point) after surgery. These data were collected using a semi-intelligent SMS text messaging platform to follow up with the patient at home after ambulatory surgery. Univariate and multivariate analyses were performed to analyze the risk factors for pain. Results: We analyzed 6099 patients. On the day after the surgery, 5.2% (318/6099) of the patients presented with moderate-to-severe pain: 5.9% (248/4187) in the general or regional anesthesia group and 3.7% (70/1912) in the local anesthesia group. At 7 days after the surgery, 18.6% (1135/6099) of the patients presented with moderate-to-severe pain, including 21.3% (892/4187) of the patients in the general or regional anesthesia group and 12.7% (243/1912) of the patients in the local anesthesia group. General surgery (odds ratio [OR] 1.54, 95% CI 1.23-1.92; P<.01) and orthopedic surgery (OR 1.66, 95% CI 1.42-1.94; P<.01) were associated with more late postoperative pain risk. Male gender (OR 0.66, 95% CI 0.57-0.76; P<.01), ophthalmology surgery (OR 0.51, 95% CI 0.42-0.62; P<.01), and gynecologic surgery (OR 0.67, 95% CI 0.50-0.88; P=.01) were associated with less late postoperative pain risk. The rate of emergency consultation or rehospitalization at 7 days after the surgery was 11.1% (679/6099). Late postoperative pain (OR 2.54, 95% CI 1.98-3.32; P<.001), general surgery (OR 2.15, 95% CI 1.65-2.81; P<.001), and urology surgery (OR 1.62, 95% CI 1.06-2.43; P=.02) increased the risk of emergency consultation or rehospitalization. Orthopedic surgery (OR 0.79, 95% CI 0.63-0.99; P=.04) and electroconvulsive therapy (OR 0.43, 95% CI 0.27-0.65; P<.001) were associated with less rates of emergency consultation or rehospitalization. Conclusions: Our study shows that postoperative pain at 7 days after ambulatory surgery was reported in more than 18% of the cases, which was also associated with an increase in the emergency consultation or rehospitalization rates. UR - https://periop.jmir.org/2022/1/e33276 UR - http://dx.doi.org/10.2196/33276 UR - http://www.ncbi.nlm.nih.gov/pubmed/36282551 ID - info:doi/10.2196/33276 ER - TY - JOUR AU - Tran-Nguyen, Kevin AU - Berger, Caroline AU - Bennett, Roxanne AU - Wall, Michelle AU - Morin, N. Suzanne AU - Rajabiyazdi, Fateme PY - 2022/10/17 TI - Mobile App Prototype in Older Adults for Postfracture Acute Pain Management: User-Centered Design Approach JO - JMIR Aging SP - e37772 VL - 5 IS - 4 KW - older adults KW - mobile app KW - skeletal fracture KW - usability KW - patient-centered KW - human-centered design KW - digital health KW - eHealth KW - mobile health KW - mHealth KW - acute pain self-management KW - mobile phone N2 - Background: Postfracture acute pain is often inadequately managed in older adults. Mobile health (mHealth) technologies can offer opportunities for self-management of pain; however, insufficient apps exist for acute pain management after a fracture, and none are designed for an older adult population. Objective: This study aims to design, develop, and evaluate an mHealth app prototype using a human-centered design approach to support older adults in the self-management of postfracture acute pain. Methods: This study used a multidisciplinary and user-centered design approach. Overall, 7 stakeholders (ie, 1 clinician-researcher specialized in internal medicine, 2 user experience designers, 1 computer science researcher, 1 clinical research assistant researcher, and 2 pharmacists) from the project team, together with 355 external stakeholders, were involved throughout our user-centered development process that included surveys, requirement elicitation, participatory design workshops, mobile app design and development, mobile app content development, and usability testing. We completed this study in 3 phases. We analyzed data from prior surveys administered to 305 members of the Canadian Osteoporosis Patient Network and 34 health care professionals to identify requirements for designing a low-fidelity prototype. Next, we facilitated 4 participatory design workshops with 6 participants for feedback on content, presentation, and interaction with our proposed low-fidelity prototype. After analyzing the collected data using thematic analysis, we designed a medium-fidelity prototype. Finally, to evaluate our medium-fidelity prototype, we conducted usability tests with 10 participants. The results informed the design of our high-fidelity prototype. Throughout all the phases of this development study, we incorporated inputs from health professionals to ensure the accuracy and validity of the medical content in our prototypes. Results: We identified 3 categories of functionalities necessary to include in the design of our initial low-fidelity prototype: the need for support resources, diary entries, and access to educational materials. We then conducted a thematic analysis of the data collected in the design workshops, which revealed 4 themes: feedback on the user interface design and usability, requests for additional functionalities, feedback on medical guides and educational materials, and suggestions for additional medical content. On the basis of these results, we designed a medium-fidelity prototype. All the participants in the usability evaluation tests found the medium-fidelity prototype useful and easy to use. On the basis of the feedback and difficulties experienced by participants, we adjusted our design in preparation for the high-fidelity prototype. Conclusions: We designed, developed, and evaluated an mHealth app to support older adults in the self-management of pain after a fracture. The participants found our proposed prototype useful for managing acute pain and easy to interact with and navigate. Assessment of the clinical outcomes and long-term effects of our proposed mHealth app will be evaluated in the future. UR - https://aging.jmir.org/2022/4/e37772 UR - http://dx.doi.org/10.2196/37772 UR - http://www.ncbi.nlm.nih.gov/pubmed/36251348 ID - info:doi/10.2196/37772 ER - TY - JOUR AU - Browne, D. Jonathan AU - Vaninetti, Michael AU - Giard, David AU - Kostas, Konstantinos AU - Dave, Ankur PY - 2022/10/13 TI - An Evaluation of a Mobile App for Chronic Low Back Pain Management: Prospective Pilot Study JO - JMIR Form Res SP - e40869 VL - 6 IS - 10 KW - back pain KW - chronic pain KW - mobile KW - app KW - multidisciplinary care KW - biopsychosocial KW - self-management KW - mHealth KW - mobile health KW - mobile app N2 - Background: Chronic low back pain is challenging to manage due to multidisciplinary considerations. It has substantial socioeconomic impacts and cannot be simply treated with pharmacotherapy, nonsurgical intervention, or spine surgery. Medical consensus recommends optimizing conservative self-management therapies (eg, home exercise, wellness strategies, yoga, etc) as first-line treatment options for chronic low back pain. However, access to these modalities is often limited and secondary to cost, convenience, and ease of use. Mobile health apps have emerged as a cost-effective and accessible option for chronic low back pain self-management. Established in-person pain programs can provide the structure for an optimal mobile app adaptation. PainNavigator (PainNavigator, Inc) is an example of a mobile app that is based on an Ascension-Illinois group?based pain program?Pain Rehabilitation Outpatient-Camp. Objective: This was a prospective pilot clinical trial that evaluated the PainNavigator platform?s utility in low back pain management to inform future trial development. Methods: A total of 75 participants who used PainNavigator were studied. Pain, Enjoyment, and General Activity (PEG-3) scale scores and scores from a brief anxiety and depression scale based on the Patient Health Questionnaire-4 (PHQ-4) were obtained at baseline and following program completion. The PEG-3 total score was used, in addition to individual items?Average Pain, Pain Effect on Enjoyment, and Pain Effect on Activity. The PHQ-4 total score was also used, in addition to other individual items, including Felt Depressed, Loss of Interest, Felt Anxious, and Difficult to Control Worry. Paired sample t tests (2-tailed) compared mean differences in scores from before and after participants received the intervention. Results: The analysis found that PEG-3 (n=27) and PHQ-4 (n=27) total scores were significantly lower upon the completion of PainNavigator (P<.001 and P=.001, respectively). The findings showed a 36% reduction in PEG-3 total scores, a 40% reduction in pain intensity, and a 40% reduction in PHQ-4 total scores. Scores for individual PEG-3 scale and PHQ-4 items also significantly decreased. All PEG-3 measures had large effect sizes. The PHQ-4 total score and Difficult to Control Worry item had large effect sizes, while the other three measures had medium effect sizes. Conclusions: These findings show that PainNavigator has clinical significance in managing chronic low back pain and can be easily utilized to improve patient care. All PEG-3 scale and PHQ-4 measures significantly improved following the use of the platform, supporting the multidimensional, biopsychosocial approach to low back pain management. Differences in effect sizes may inform quality improvement investigations, such as optimizing features that impact measures with only medium effect sizes. This feasibility study demonstrates an effective protocol, and it will inform future, more extensive randomized controlled trials. UR - https://formative.jmir.org/2022/10/e40869 UR - http://dx.doi.org/10.2196/40869 UR - http://www.ncbi.nlm.nih.gov/pubmed/36227637 ID - info:doi/10.2196/40869 ER - TY - JOUR AU - Soret, Lou AU - Gendron, Nicolas AU - Rivet, Nadia AU - Chocron, Richard AU - Macraigne, Laure AU - Clausse, Darless AU - Cholley, Bernard AU - Gaussem, Pascale AU - Smadja, M. David AU - Darnige, Luc PY - 2022/10/12 TI - Pain Assessment Using Virtual Reality Facemask During Bone Marrow Aspiration: Prospective Study Including Propensity-Matched Analysis JO - JMIR Serious Games SP - e33221 VL - 10 IS - 4 KW - bone marrow aspiration KW - pain assessment KW - virtual reality facemask KW - anxiety KW - hematology KW - virtual reality KW - VR KW - haematology KW - haematological KW - hematological KW - hematological disorder KW - pain KW - pain scale KW - medical procedure KW - bone marrow KW - facemask KW - diagnosis KW - monitoring N2 - Background: Bone marrow aspiration (BMA) is a medical procedure necessary to the diagnosis and monitoring of patients with hematological or nonhematological disorders. This procedure is considered painful, and patients are generally anxious before and during BMA. Objective: This study assesses the effect of immersive virtual reality on pain during BMA. Methods: This observational prospective and monocentric study enrolled 105 consecutive patients who underwent sternal BMA with lidocaine anesthesia. The study was carried on during 2 periods. First, virtual reality facemask (VRF) was proposed to all patients in the absence of exclusion criteria. During the second period, BMA was performed without the VRF. For all patients, pain intensity after the procedure was assessed using a 10-point numerical pain rating scale (NPRS). All analyses were performed on propensity score?matched cohort (with or without VRF) to evaluate efficacy on NRPS levels. Results: The final matched cohort included 12 patients in the VRF group and 24 in the control group. No difference in anxiety level before BMA evaluated by the patient and by the operator was observed between groups (P=.71 and .42 respectively). No difference of NPRS was observed using VRF when compared to control group (median NPRS 3.8, IQR 2.0-6.3 vs 3.0, IQR 1.9-3.0, respectively; P=.09). Conclusions: Our study did not prove the efficacy of VRF to reduce pain during BMA. UR - https://games.jmir.org/2022/4/e33221 UR - http://dx.doi.org/10.2196/33221 UR - http://www.ncbi.nlm.nih.gov/pubmed/36222814 ID - info:doi/10.2196/33221 ER - TY - JOUR AU - Sadik, Omowunmi AU - Schaffer, David J. AU - Land, Walker AU - Xue, Huize AU - Yazgan, Idris AU - Kafesçiler, Korkut AU - Sungur, Mürvet PY - 2022/9/29 TI - A Bayesian Network Concept for Pain Assessment JO - JMIR Biomed Eng SP - e35711 VL - 7 IS - 2 KW - pain science KW - pain biomarkers KW - novel biosensors KW - Bayesian network KW - artificial intelligence KW - AI evidential reasoning KW - pain self-report KW - probability of pain levels KW - cyclooxygenase-2 KW - COX-2 KW - inducible nitric oxide synthase KW - iNOS UR - https://biomedeng.jmir.org/2022/2/e35711 UR - http://dx.doi.org/10.2196/35711 UR - http://www.ncbi.nlm.nih.gov/pubmed/27774989 ID - info:doi/10.2196/35711 ER - TY - JOUR AU - Merlot, Benjamin AU - Dispersyn, Garance AU - Husson, Zoé AU - Chanavaz-Lacheray, Isabella AU - Dennis, Thomas AU - Greco-Vuilloud, Juliette AU - Fougère, Maxime AU - Potvin, Stéphane AU - Cotty-Eslous, Maryne AU - Roman, Horace AU - Marchand, Serge PY - 2022/9/21 TI - Pain Reduction With an Immersive Digital Therapeutic Tool in Women Living With Endometriosis-Related Pelvic Pain: Randomized Controlled Trial JO - J Med Internet Res SP - e39531 VL - 24 IS - 9 KW - digital treatment KW - digital intervention KW - virtual reality KW - pelvic pain KW - endometriosis KW - digital therapeutics KW - chronic pain KW - randomized controlled trial KW - RCT KW - pain KW - women's health KW - eHealth KW - digital health KW - endometrium KW - pelvis KW - pelvic KW - efficacy KW - effectiveness KW - gynecology KW - gynecologist KW - sexual health KW - reproductive health N2 - Background: Chronic pelvic pain is a common and disabling condition in women living with endometriosis. Pharmacological and surgical treatments are not always effective at controlling pain and present important restrictions. Digital therapeutics (DTx) are emerging as major nonpharmacological alternatives that aim to extend the analgesic therapeutic arsenal of patients. Objective: In this randomized controlled trial (RCT), we aimed to measure the immediate and 4-hour persisting effects of a single use 20-minute DTx (Endocare) on pain in women experiencing pelvic pain due to endometriosis. Methods: A total of 45 women with endometriosis participated in a randomized controlled study comparing the analgesic effect of a single use of a virtual reality digital treatment named Endocare (n=23, 51%) to a 2D digital control (n=22, 49%). Perceived pain and pain relief were measured before the treatment and 15, 30, 45, 60, and 240 minutes after the end of the treatment. Results: The clustered posttreatment pain was significantly reduced compared to the pretreatment for both Endocare and the control group (all P<.01). Endocare was significantly more effective than the control group (all P<.01). Endocare decreased the mean pain intensity from 6.0 (SD 1.31) before the treatment to 4.5 (SD 1.71) posttreatment, while the control only decreased it from 5.7 (SD 1.36) to 5.0 (SD 1.43). When comparing each posttreatment measures to the pretest, Endocare significantly reduced pain perception for all points in time up to 4 hours posttreatment. The differences did not reached significance for the control group. Moreover, Endocare was significantly superior to the control group 15, 30, and 45 minutes after the treatment (all P<.001). The mean perceived pain relief was significantly higher for Endocare at 28% (SD 2%) compared to the control, which was 15% (SD 1%) for all the posttreatment measurements (all P>.05). Conclusions: Our study aimed to test the effects of a single use of a DTx treatment on reported pain at different time points in women diagnosed with endometriosis experiencing moderate-to-severe pelvic pain. Importantly, our results support that Endocare, a virtual reality immersive treatment, significantly reduce pain perception compared to a digital control in women living with endometriosis. Interestingly, we are the first to notice that the effect persisted up to 4 hours posttreatment. Trial Registration: ClinicalTrials.gov NCT04650516; https://tinyurl.com/2a2eu9wv UR - https://www.jmir.org/2022/9/e39531 UR - http://dx.doi.org/10.2196/39531 UR - http://www.ncbi.nlm.nih.gov/pubmed/36129733 ID - info:doi/10.2196/39531 ER - TY - JOUR AU - Valentijn, Peter Pim AU - Tymchenko, Liza AU - Jacobson, Teddy AU - Kromann, Jakob AU - Biermann, W. Claus AU - AlMoslemany, Atef Mohamed AU - Arends, Ymkje Rosa PY - 2022/9/6 TI - Digital Health Interventions for Musculoskeletal Pain Conditions: Systematic Review and Meta-analysis of Randomized Controlled Trials JO - J Med Internet Res SP - e37869 VL - 24 IS - 9 KW - eHealth KW - models of care KW - mobile health KW - mHealth KW - digital health KW - pain KW - telehealth KW - telemedicine KW - disability KW - function KW - quality of life KW - mobile phone N2 - Background: Digital health solutions can provide populations with musculoskeletal pain with high-reach, low-cost, easily accessible, and scalable patient education and self-management interventions that meet the time and resource restrictions. Objective: The main objective of this study was to determine the effectiveness of digital health interventions for people with musculoskeletal pain conditions (ie, low back pain, neck pain, shoulder pain, knee pain, elbow pain, ankle pain, and whiplash). Methods: A systematic review and meta-analysis was conducted. We searched PubMed and Cochrane Central Register of Controlled Trials (from 1974 to August 2021) and selected randomized controlled trials of digital health interventions in the target population of patients with musculoskeletal pain with a minimum follow-up of 1 month. A total of 2 researchers independently screened and extracted the data. Results: A total of 56 eligible studies were included covering 9359 participants, with a mean follow-up of 25 (SD 15.48) weeks. In moderate-quality evidence, digital health interventions had a small effect on pain (standardized mean difference [SMD] 0.19, 95% CI 0.06-0.32), disability (SMD 0.14, 95% CI 0.03-0.25), quality of life (SMD 0.22, 95% CI 0.07-0.36), emotional functioning (SMD 0.24, 95% CI 0.12-0.35), and self-management (SMD 0.14, 95% CI 0.05-0.24). Conclusions: Moderate-quality evidence supports the conclusion that digital health interventions are effective in reducing pain and improving functioning and self-management of musculoskeletal pain conditions. Low-quality evidence indicates that digital health interventions can improve the quality of life and global treatment. Little research has been conducted on the influence of digital health on expenses, knowledge, overall improvement, range of motion, muscle strength, and implementation fidelity. Trial Registration: PROSPERO CRD42022307504; https://tinyurl.com/2cd25hus UR - https://www.jmir.org/2022/9/e37869 UR - http://dx.doi.org/10.2196/37869 UR - http://www.ncbi.nlm.nih.gov/pubmed/36066943 ID - info:doi/10.2196/37869 ER - TY - JOUR AU - Fioratti, Iuri AU - Miyamoto, Cristiane Gisela AU - Fandim, Vitorino Junior AU - Ribeiro, Pontes Camila Pereira AU - Batista, Domingues Geovana AU - Freitas, Evangelista Gabriella AU - Palomo, Santos Andressa AU - Reis, dos Felipe José Jandré AU - Costa, Pena Leonardo Oliveira AU - Maher, G. Christopher AU - Saragiotto, Tirotti Bruno PY - 2022/8/30 TI - Feasibility, Usability, and Implementation Context of an Internet-Based Pain Education and Exercise Program for Chronic Musculoskeletal Pain: Pilot Trial of the ReabilitaDOR Program JO - JMIR Form Res SP - e35743 VL - 6 IS - 8 KW - telerehabilitation KW - musculoskeletal pain KW - implementation science KW - feasibility study KW - chronic pain KW - pain KW - pilot study KW - eHealth KW - exercise KW - telehealth KW - self-management N2 - Background: Internet-based self-management programs and telerehabilitation initiatives have increased and have been extensively used for delivering health care in many areas. These programs overcome common barriers that patients face with traditional face-to-face health care, such as travel expenditures, lack of time, and high demand on the public health system. During the COVID-19 pandemic, this mode of web-based health care delivery had become more popular. However, there is still a lack of studies testing this mode of delivery in low- and middle-income countries. To gain a better understanding of the context, feasibility, and factors involved in the implementation of a web-based program, pilot and implementation studies are necessary. These studies can better inform whether a strategy is feasible, acceptable, and adequate for its purposes and for optimizing resource allocation. Objective: This study aims to evaluate the feasibility, usability, and implementation context of a self-management internet-based program based on exercises and pain education (ReabilitaDOR) in people with chronic musculoskeletal pain and to compare this program with a program using only a web-based self-management booklet. Methods: The study design was a parallel pilot study of a prospectively registered, assessor-blinded, 2-arm randomized controlled trial with economic evaluation. This study was performed using waiting lists of physiotherapy and rehabilitation centers and advertisements on social media networks. The participants were 65 patients with chronic musculoskeletal pain aged between 18 and 60 years. The effects of an 8-week telerehabilitation program based on exercises and pain education (intervention group) were compared with those of a program based only on a web-based self-management booklet (control group). The main outcome measures were implementation outcomes of patients? perceptions of acceptability, appropriateness, feasibility, and usability of the program and the societal costs and feasibility of the main trial at 8-week posttreatment follow-up. Adverse events were also analyzed. Results: In total, 56 participants were analyzed at the 8-week follow-up. The intervention group showed responses with a mean of 4.5 (SD 0.6) points for acceptability, 4.5 (SD 0.5) points for appropriateness, and 4.5 (SD 0.6) points for feasibility measured on a 1 to 5 scale. All patients in the intervention group showed satisfactory responses to the system usability outcome. There is satisfactory evidence for the feasibility of the main trial. For costs related to the interventions, health care, patients, and loss of productivity at 8 weeks, we found a total expenditure of US $278.30 per patient in the intervention group and US $141.52 per patient in the control group. No adverse events were reported during the intervention period. Conclusions: We found that the ReabilitaDOR program is feasible, appropriate, and acceptable from the users? implementation perspective. This system was considered usable by all the participants, and the main trial seemed feasible. Cost data were viable to be collected, and the program is likely to be safe. Trial Registration: ClinicalTrials.gov NCT04274439; https://clinicaltrials.gov/ct2/show/NCT04274439 UR - https://formative.jmir.org/2022/8/e35743 UR - http://dx.doi.org/10.2196/35743 UR - http://www.ncbi.nlm.nih.gov/pubmed/35776863 ID - info:doi/10.2196/35743 ER - TY - JOUR AU - Ashtari, Sadaf AU - Taylor, Daniel Adam PY - 2022/8/25 TI - The Internet Knows More Than My Physician: Qualitative Interview Study of People With Rare Diseases and How They Use Online Support Groups JO - J Med Internet Res SP - e39172 VL - 24 IS - 8 KW - online peer support group KW - genetic disorders KW - pain management KW - Ehlers-Danlos syndrome KW - EDS KW - chronic pain KW - health care provider KW - pain mitigation techniques N2 - Background: Patients struggling with rare diseases may face challenges caused by care providers being unfamiliar with their condition. The life span of people with rare diseases may be the same as that of healthy people, but their quality of life is different. Patients with chronic pain are constantly looking for ways to mitigate their pain. Pain killers are not a permanent solution. In addition to the medical and nonmedical costs of rare diseases for both patients and health care providers, there is a need for sustainable sources of information that are available to help with pain and improve their quality of life, with the goal of reducing physician visits and hospital admissions. Objective: This study investigated the challenges that patients with genetic disorders face in managing their health conditions and finding disease-related information as well as the effect of online peer support groups on pain mitigation and care management. Methods: Interviews were conducted via Zoom between July 2021 and December 2021. Eligible participants were those who were aged >18 years, had a medical diagnosis of any type of Ehlers-Danlos syndrome (EDS) with chronic pain, and were members of any support group. Participants were recruited through an announcement in the research and survey section of The Ehlers-Danlos Syndrome Society web page. Interviews were analyzed using the framework approach. Data were systematically searched to identify patterns, analyze them, and identify themes. Interview audio files were transcribed and independently coded by two researchers (SA and AT). Through an iterative process, a final coding table was agreed upon by the researchers and used to thematically analyze the data. Results: We interviewed 30 participants (mean age 37.7, SD 15 years; n=28, 93% were women; n=23, 77% were residing in the United States). Thematic analysis revealed that participants (patients with EDS) were constantly in pain and most of them have not received accurate and timely diagnoses for many years. They expressed their challenges with health care providers regarding diagnosis and treatment, and complained about their providers? lack of support and knowledge. Participants? main sources of information were web-based searches, academic journals, The Ehlers-Danlos Syndrome Society web page, and online peer support groups on Facebook, Reddit, Twitter, and Instagram. Although pain killers, cannabis, and opioids are providing some pain relief, most patients (28/30, 93%) focused on nonmedical approaches, such as hot or ice packs, physical therapy, exercises, massage, mindfulness, and meditation. Conclusions: This study highlights the information gap between health care providers and patients with genetic disorders. Patients with EDS seek access to information from different web-based sources. To meet the needs of patients with genetic disorders, future interventions via web-based resources for improving the quality of care must be considered by health care professionals and government agencies. UR - https://www.jmir.org/2022/8/e39172 UR - http://dx.doi.org/10.2196/39172 UR - http://www.ncbi.nlm.nih.gov/pubmed/36006679 ID - info:doi/10.2196/39172 ER - TY - JOUR AU - Stoppok, Paula AU - Teufel, Martin AU - Jahre, Lisa AU - Rometsch, Caroline AU - Müßgens, Diana AU - Bingel, Ulrike AU - Skoda, Eva-Maria AU - Bäuerle, Alexander PY - 2022/8/17 TI - Determining the Influencing Factors on Acceptance of eHealth Pain Management Interventions Among Patients With Chronic Pain Using the Unified Theory of Acceptance and Use of Technology: Cross-sectional Study JO - JMIR Form Res SP - e37682 VL - 6 IS - 8 KW - eHealth KW - eHealth interventions KW - Unified Theory of Acceptance and Use of Technology KW - UTAUT KW - chronic pain KW - pain management KW - acceptance N2 - Background: Chronic pain is a complex disease with high prevalence rates, and many individuals who are affected do not receive adequate treatment. As a complement to conventional therapies, eHealth interventions could provide many benefits to a multimodal treatment approach for patients with chronic pain, whereby future use is associated with the acceptance of these interventions. Objective: This study aims to assess the acceptance of eHealth pain management interventions among patients with chronic pain and identify the influencing factors on acceptance. A further objective of the study is to evaluate the viability of the Unified Theory of Acceptance and Use of Technology (UTAUT) model and compare it with its extended version in terms of explained variance of acceptance. Methods: We performed a cross-sectional web-based study. In total, 307 participants with chronic pain, as defined according to the International Association for the Study of Pain criteria, were recruited through flyers, posters, and web-based inquiries between December 2020 and July 2021. In addition to sociodemographic and medical data, the assessment included validated psychometric instruments and an extended version of the well-established UTAUT model. For statistical analyses, group comparisons and multiple hierarchical regression analyses were performed. Results: The acceptance of eHealth pain management interventions among patients with chronic pain was overall moderate to high (mean 3.67, SD 0.89). There was significant difference in acceptance among age groups (W=9674.0; r=0.156; P=.04). Effort expectancy (?=.37; P<.001), performance expectancy (?=.33; P<.001), and social influence (?=.34; P<.001) proved to be the most important predictors of acceptance. The extended UTAUT (including the original UTAUT factors as well as sociodemographic, medical, and eHealth-related factors) model explained 66.4% of the variance in acceptance, thus supporting the viability of the model. Compared with the original UTAUT model (performance expectancy, effort expectancy, and social influence), the extended model explained significantly more variance (F25,278=1.74; P=.02). Conclusions: Given the association between acceptance and future use, the knowledge of the influencing factors on acceptance should be used in the development and promotion of eHealth pain management interventions. Overall, the acceptance of eHealth pain management interventions was moderate to high. In total, 8 predictors proved to be significant predictors of acceptance. The UTAUT model is a valuable instrument for determining acceptance as well as the factors that influence acceptance of eHealth pain management interventions among patients with chronic pain. The extended UTAUT model provided the greatest predictive value for acceptance. UR - https://formative.jmir.org/2022/8/e37682 UR - http://dx.doi.org/10.2196/37682 UR - http://www.ncbi.nlm.nih.gov/pubmed/35976199 ID - info:doi/10.2196/37682 ER - TY - JOUR AU - Lluesma-Vidal, Marta AU - Carcelén González, Raquel AU - García-Garcés, Laura AU - Sánchez-López, I. María AU - Peyro, Loreto AU - Ruiz-Zaldibar, Cayetana PY - 2022/8/9 TI - Effect of Virtual Reality on Pediatric Pain and Fear During Procedures Involving Needles: Systematic Review and Meta-analysis JO - JMIR Serious Games SP - e35008 VL - 10 IS - 3 KW - virtual reality KW - pain KW - fear KW - pediatric KW - needle KW - child KW - injection KW - VR KW - systematic review KW - meta-analysis KW - paediatric N2 - Background: Virtual reality (VR) is used as a distraction measure during painful clinical procedures associated with the use of needles. These procedures include vaccinations, blood draws, or the administration of medications, which can cause children to feel increased levels of pain and fear. Objective: The objective of this study was to collect and analyze the current evidence regarding the effectiveness of VR as a tool to distract children from pain and fear during needle procedures as compared to that of standard techniques. Methods: A systematic review and meta-analysis was performed. We included randomized clinical trials (RCTs) or quasi-RCTs with participants younger than 21 years who underwent needle procedures in which the main distraction measure used was VR and where the main outcome measure was pain. The databases searched included the PubMed, Web of Science, Scopus, PsycINFO, CINAHL, and Cochrane libraries. In this systematic review, the studies were analyzed by applying the Critical Appraisal Skills Program guide in Spanish and the Jadad scale. In the meta-analysis, the effect size of the studies was analyzed based on the results for pain and fear in children. Results: From 665 unique search results, 21 studies were included in this systematic review, most of which reported low methodological quality. The study sample cohorts ranged from a minimum of 15 participants to a maximum of 220 participants. Ten studies were included in the meta-analysis. The global effect of using VR as a distraction measure was a significant reduction in pain (inverse variance [IV] ?2.37, 95% CI ?3.20 to ?1.54; Z=5.58; P<.001) and fear (IV ?1.26, 95% CI ?1.89 to ?0.63; Z=3.92; P<.001) in children in the experimental groups. Conclusions: The quality of the studies was mostly low. The main limitations were the impossibility of blinding the participants and health care personnel to the VR intervention. Nonetheless, the use of VR as a distraction measure was effective in reducing pain and fear in children during procedures involving needles. UR - https://games.jmir.org/2022/3/e35008 UR - http://dx.doi.org/10.2196/35008 UR - http://www.ncbi.nlm.nih.gov/pubmed/35943776 ID - info:doi/10.2196/35008 ER - TY - JOUR AU - Terzulli, Claire AU - Melchior, Meggane AU - Goffin, Laurent AU - Faisan, Sylvain AU - Gianesini, Coralie AU - Graff, Denis AU - Dufour, André AU - Laroche, Edouard AU - Chauvin, Chloé AU - Poisbeau, Pierrick PY - 2022/7/29 TI - Effect of Virtual Reality Hypnosis on Pain Threshold and Neurophysiological and Autonomic Biomarkers in Healthy Volunteers: Prospective Randomized Crossover Study JO - J Med Internet Res SP - e33255 VL - 24 IS - 7 KW - virtual reality KW - hypnosis KW - pain KW - analgesia KW - autonomic changes KW - thermal pain KW - physiological KW - nervous system KW - heat pain N2 - Background: Virtual reality hypnosis (VRH) is a promising tool to reduce pain. However, the benefits of VRH on pain perception and on the physiological expression of pain require further investigation. Objective: In this study, we characterized the effects of VRH on the heat pain threshold among adult healthy volunteers while monitoring several physiological and autonomic functions. Methods: Sixty healthy volunteers were prospectively included to receive nociceptive stimulations. The first set of thermal stimuli consisted of 20 stimulations at 60°C (duration 500 milliseconds) to trigger contact heat evoked potentials (CHEPs). The second set of thermal stimuli consisted of ramps (1°C/second) to determine the heat pain threshold of the participants. Electrocardiogram, skin conductance responses, respiration rate, as well as the analgesia nociception index were also recorded throughout the experiment. Results: Data from 58 participants were analyzed. There was a small but significant increase in pain threshold in VRH (50.19°C, SD 1.98°C) compared to that in the control condition (mean 49.45°C, SD 1.87; P<.001, Wilcoxon matched-pairs signed-rank test; Cohen d=0.38). No significant effect of VRH on CHEPs and heart rate variability parameters was observed (all P>0.5; n=22 and n=52, respectively). During VRH, participants exhibited a clear reduction in their autonomic sympathetic tone, as shown by the lower number of nonspecific skin conductance peak responses (P<.001, two-way analysis of variance; n=39) and by an increase in the analgesia nociception index (P<.001, paired t-test; n=40). Conclusions: The results obtained in this study support the idea that VRH administration is effective at increasing heat pain thresholds and impacts autonomic functions among healthy volunteers. As a nonpharmacological intervention, VRH has beneficial action on acute experimental heat pain. This beneficial action will need to be evaluated for the treatment of other types of pain, including chronic pain. UR - https://www.jmir.org/2022/7/e33255 UR - http://dx.doi.org/10.2196/33255 UR - http://www.ncbi.nlm.nih.gov/pubmed/35904872 ID - info:doi/10.2196/33255 ER - TY - JOUR AU - Tuck, Natalie AU - Pollard, Catherine AU - Good, Clinton AU - Williams, Caitlin AU - Lewis, Gwyn AU - Hames, Murray AU - Aamir, Tipu AU - Bean, Debbie PY - 2022/7/13 TI - Active Virtual Reality for Chronic Primary Pain: Mixed Methods Randomized Pilot Study JO - JMIR Form Res SP - e38366 VL - 6 IS - 7 KW - chronic pain KW - virtual reality KW - VR KW - rehabilitation KW - serious games KW - physiotherapy KW - pain management KW - acceptability KW - intervention KW - feasibility N2 - Background: The modern management of chronic pain is largely focused on improving functional capacity (often despite ongoing pain) by using graded activation and exposure paradigms. However, many people with chronic pain find functional activation programs aversive, and dropout rates are high. Modern technologies such as virtual reality (VR) could provide a more enjoyable and less threatening way for people with chronic pain to engage in physical activity. Although VR has been successfully used for pain relief in acute and chronic pain settings, as well as to facilitate rehabilitation in conditions such as stroke and cerebral palsy, it is not known whether VR can also be used to improve functional outcomes in people with chronic pain. Objective: This study aimed to assess the feasibility of conducting an adequately powered randomized controlled trial (RCT) to test the efficacy of VR in a chronic pain treatment center and assess the acceptability of an active VR treatment program for patients in this setting. Methods: For this mixed methods pilot study, which was designed to test the feasibility and acceptability of the proposed study methods, 29 people seeking treatment for chronic pain were randomized to an active VR intervention or physiotherapy treatment as usual (TAU). The TAU group completed a 6-week waitlist before receiving standard treatment to act as a no-treatment control group. The VR intervention comprised twice-weekly immersive and embodied VR sessions using commercially available gaming software, which was selected to encourage movement. A total of 7 VR participants completed semistructured interviews to assess their perception of the intervention. Results: Of the 99 patients referred to physiotherapy, 53 (54%) were eligible, 29 (29%) enrolled, and 17 (17%) completed the trial, indicating that running an adequately powered RCT in this setting would not be feasible. Despite this, those in the VR group showed greater improvements in activity levels, pain intensity, and pain interference and reported greater treatment satisfaction and perceived improvement than both the waitlist and TAU groups. Relative effect sizes were larger when VR was compared with the waitlist (range small to very large) and smaller when VR was compared with TAU (range none to medium). The qualitative analysis produced the following three themes: VR is an enjoyable alternative to traditional physiotherapy, VR has functional and psychological benefits despite continued pain, and a well-designed VR setup is important. Conclusions: The active VR intervention in this study was highly acceptable to participants, produced favorable effects when compared with the waitlist, and showed similar outcomes as those of TAU. These findings suggest that a confirmatory RCT is warranted; however, substantial barriers to recruitment indicate that incentivizing participation and using a different treatment setting or running a multicenter trial are needed. UR - https://formative.jmir.org/2022/7/e38366 UR - http://dx.doi.org/10.2196/38366 UR - http://www.ncbi.nlm.nih.gov/pubmed/35830224 ID - info:doi/10.2196/38366 ER - TY - JOUR AU - Wang, Grace AU - Yang, Manshu AU - Hong, Mindy AU - Krauss, Jeffrey AU - Bailey, F. Jeannie PY - 2022/6/27 TI - Clinical Outcomes After a Digital Musculoskeletal Program for Acute and Subacute Pain: Observational, Longitudinal Study With Comparison Group JO - JMIR Rehabil Assist Technol SP - e38214 VL - 9 IS - 2 KW - telemedicine KW - acute KW - subacute KW - musculoskeletal KW - pain KW - function KW - clinical KW - quality of life KW - intervention KW - longitudinal study KW - physical therapy KW - physiotherapy KW - physical therapist KW - physiotherapist KW - exercise KW - physical activity KW - telehealth KW - eHealth KW - digital health KW - patient education KW - education material KW - education resource KW - health resource KW - mHealth KW - mobile health KW - health app KW - observational study KW - video consult KW - eConsult KW - virtual care N2 - Background: Telerehabilitation for musculoskeletal (MSK) conditions may produce similar or better outcomes than usual care, but most telerehabilitation studies address only chronic or postsurgical pain. Objective: We aimed to examine pain and function at 3, 6, and 12 weeks for individuals with acute and subacute MSK pain who took part in a digital MSK program versus a nonparticipant comparison group. Methods: We conducted an observational, longitudinal study with a nonparticipant comparison group. The intervention group had video visits with physical therapists who recommended exercise therapies and educational articles delivered via an app. Nonparticipants were those who were registered but unable to participate because their benefit coverage had not yet begun. We collected pain and function outcomes through surveys delivered at 3-, 6-, and 12-week follow-ups. We conducted descriptive analyses, unadjusted regression, and mixed effects regression adjusting for baseline characteristics, time as fixed effects, and a time*group interaction term. Results: The analysis included data from 675 nonparticipants and 262 intervention group participants. Compared to baseline, the intervention group showed significantly more pain improvement at 3, 6, and 12 weeks versus nonparticipants after adjusting for baseline factors. Specifically, the intervention group?s pain scores decreased by 55.8% at 3 weeks versus baseline, 69.1% at 6 weeks, and 73% at 12 weeks. The intervention group?s adjusted pain scores decreased from 43.7 (95% CI 41.1-46.2) at baseline to 19.3 (95% CI 16.8-21.8) at 3 weeks to 13.5 (95% CI 10.8-16.2) at 6 weeks to 11.8 (95% CI 9-14.6) at 12 weeks. In contrast, nonparticipants? pain scores decreased by 30.8% at 3 weeks versus baseline, 45.8% at 6 weeks, and 46.7% at 12 weeks. Nonparticipants? adjusted pain scores decreased from 43.8 (95% CI 42-45.5) at baseline to 30.3 (95% CI 27.1-33.5) at 3 weeks to 23.7 (95% CI 20-27.5) at 6 weeks to 23.3 (95% CI 19.6-27) at 12 weeks. After adjustments, the percentage of participants reporting that pain was better or much better at follow-up was significantly higher by 40.6% at 3 weeks, 31.4% at 6 weeks, and 31.2% at 12 weeks for intervention group participants versus nonparticipants. After adjustments, the percentage of participants with meaningful functional improvement at follow-up was significantly higher by 15.2% at 3 weeks and 24.6% at 12 weeks for intervention group participants versus nonparticipants. Conclusions: A digital MSK program may help to improve pain and function in the short term among those with acute and subacute MSK pain. UR - https://rehab.jmir.org/2022/2/e38214 UR - http://dx.doi.org/10.2196/38214 UR - http://www.ncbi.nlm.nih.gov/pubmed/35759317 ID - info:doi/10.2196/38214 ER - TY - JOUR AU - Dixit, Abhishek AU - Lee, Michael PY - 2022/6/24 TI - Quantification of Digital Body Maps for Pain: Development and Application of an Algorithm for Generating Pain Frequency Maps JO - JMIR Form Res SP - e36687 VL - 6 IS - 6 KW - Scalable Vector Graphics KW - SVG KW - pain drawing KW - pain location KW - Body Pain Map KW - overlap computation KW - heat map KW - pain frequency map KW - algorithm N2 - Background: Pain is an unpleasant sensation that signals potential or actual bodily injury. The locations of bodily pain can be communicated and recorded by freehand drawing on 2D or 3D (manikin) surface maps. Freehand pain drawings are often part of validated pain questionnaires (eg, the Brief Pain Inventory) and use 2D templates with undemarcated body outlines. The simultaneous analysis of drawings allows the generation of pain frequency maps that are clinically useful for identifying areas of common pain in a disease. The grid-based approach (dividing a template into cells) allows easy generation of pain frequency maps, but the grid?s granularity influences data capture accuracy and end-user usability. The grid-free templates circumvent the problem related to grid creation and selection and provide an unbiased basis for drawings that most resemble paper drawings. However, the precise capture of drawn areas poses considerable challenges in producing pain frequency maps. While web-based applications and mobile-based apps for freehand digital drawings are widely available, tools for generating pain frequency maps from grid-free drawings are lacking. Objective: We sought to provide an algorithm that can process any number of freehand drawings on any grid-free 2D body template to generate a pain frequency map. We envisage the use of the algorithm in clinical or research settings to facilitate fine-grain comparisons of human pain anatomy between disease diagnosis or disorders or as an outcome metric to guide monitoring or discovery of treatments. Methods: We designed a web-based tool to capture freehand pain drawings using a grid-free 2D body template. Each drawing consisted of overlapping rectangles (Scalable Vector Graphics elements) created by scribbling in the same area of the body template. An algorithm was developed and implemented in Python to compute the overlap of rectangles and generate a pain frequency map. The utility of the algorithm was demonstrated on drawings obtained from 2 clinical data sets, one of which was a clinical drug trial (ISRCTN68734605). We also used simulated data sets of overlapping rectangles to evaluate the performance of the algorithm. Results: The algorithm produced nonoverlapping rectangles representing unique locations on the body template. Each rectangle carries an overlap frequency that denotes the number of participants with pain at that location. When transformed into an HTML file, the output is feasibly rendered as a pain frequency map on web browsers. The layout (vertical-horizontal) of the output rectangles can be specified based on the dimensions of the body regions. The output can also be exported to a CSV file for further analysis. Conclusions: Although further validation in much larger clinical data sets is required, the algorithm in its current form allows for the generation of pain frequency maps from any number of freehand drawings on any 2D body template. UR - https://formative.jmir.org/2022/6/e36687 UR - http://dx.doi.org/10.2196/36687 UR - http://www.ncbi.nlm.nih.gov/pubmed/35749160 ID - info:doi/10.2196/36687 ER - TY - JOUR AU - Padhee, Swati AU - Nave Jr, K. Gary AU - Banerjee, Tanvi AU - Abrams, M. Daniel AU - Shah, Nirmish PY - 2022/6/23 TI - Improving Pain Assessment Using Vital Signs and Pain Medication for Patients With Sickle Cell Disease: Retrospective Study JO - JMIR Form Res SP - e36998 VL - 6 IS - 6 KW - pain management KW - pain medication KW - vital signs KW - sickle cell disease KW - machine learning N2 - Background: Sickle cell disease (SCD) is the most common inherited blood disorder affecting millions of people worldwide. Most patients with SCD experience repeated, unpredictable episodes of severe pain. These pain episodes are the leading cause of emergency department visits among patients with SCD and may last for several weeks. Arguably, the most challenging aspect of treating pain episodes in SCD is assessing and interpreting a patient?s pain intensity level. Objective: This study aims to learn deep feature representations of subjective pain trajectories using objective physiological signals collected from electronic health records. Methods: This study used electronic health record data collected from 496 Duke University Medical Center participants over 5 consecutive years. Each record contained measures for 6 vital signs and the patient?s self-reported pain score, with an ordinal range from 0 (no pain) to 10 (severe and unbearable pain). We also extracted 3 features related to medication: medication type, medication status (given or applied, or missed or removed or due), and total medication dosage (mg/mL). We used variational autoencoders for representation learning and designed machine learning classification algorithms to build pain prediction models. We evaluated our results using an accuracy and confusion matrix and visualized the qualitative data representations. Results: We designed a classification model using raw data and deep representational learning to predict subjective pain scores with average accuracies of 82.8%, 70.6%, 49.3%, and 47.4% for 2-point, 4-point, 6-point, and 11-point pain ratings, respectively. We observed that random forest classification models trained on deep represented features outperformed models trained on unrepresented data for all pain rating scales. We observed that at varying Likert scales, our models performed better when provided with medication data along with vital signs data. We visualized the data representations to understand the underlying latent representations, indicating neighboring representations for similar pain scores with a higher resolution of pain ratings. Conclusions: Our results demonstrate that medication information (the type of medication, total medication dosage, and whether the medication was given or missed) can significantly improve subjective pain prediction modeling compared with modeling with only vital signs. This study shows promise in data-driven estimated pain scores that will help clinicians with additional information about the patient?s condition, in addition to the patient?s self-reported pain scores. UR - https://formative.jmir.org/2022/6/e36998 UR - http://dx.doi.org/10.2196/36998 UR - http://www.ncbi.nlm.nih.gov/pubmed/35737453 ID - info:doi/10.2196/36998 ER - TY - JOUR AU - Meinke, Anita AU - Peters, Rick AU - Knols, H. Ruud AU - Swanenburg, Jaap AU - Karlen, Walter PY - 2022/6/10 TI - Feedback on Trunk Movements From an Electronic Game to Improve Postural Balance in People With Nonspecific Low Back Pain: Pilot Randomized Controlled Trial JO - JMIR Serious Games SP - e31685 VL - 10 IS - 2 KW - low back pain KW - postural balance KW - exergame KW - postural feedback KW - motor control KW - kinesiophobia KW - inertial measurement unit KW - randomized controlled trial N2 - Background: Postural balance is compromised in people with low back pain, possibly by changes in motor control of the trunk. Augmenting exercising interventions with sensor-based feedback on trunk posture and movements might improve postural balance in people with low back pain. Objective: We hypothesized that exercising with feedback on trunk movements reduces sway in anterior-posterior direction during quiet standing in people with low back pain. Secondary outcomes were lumbar spine and hip movement assessed during box lift and waiter bow tasks, as well as participant-reported outcomes. Adherence to the exercising intervention was also examined. Methods: A randomized controlled trial was conducted with the intervention group receiving unsupervised home exercises with visual feedback using the Valedo Home, an exergame based on 2 inertial measurement units. The control group received no intervention. Outcomes were recorded by blinded staff during 4 visits (T1-T4) at University Hospital Zurich. The intervention group performed 9 sessions of 20 minutes in the 3 weeks between T2 and T3 and were instructed to exercise at their own convenience between T3 and T4. Postural balance was assessed on a force platform. Lumbar spine and hip angles were obtained from 3 inertial measurement units. The assessments included pain intensity, disability, quality of life, and fear of movement questionnaires. Results: A total of 32 participants with nonspecific low back pain completed the first assessment T1, and 27 (84%) participants were randomized at T2 (n=14, 52% control and n=13, 48% intervention). Intention-to-treat analysis revealed no significant difference in change in anterior-posterior sway direction during the intervention period with a specified schedule (T2-T3) between the groups (W=99; P=.36; r=0.07). None of the outcomes showed significant change in accordance with our hypotheses. The intervention group completed a median of 61% (55/90; range 2%-99%) of the exercises in the predefined training program. Adherence was higher in the first intervention period with a specified schedule. Conclusions: The intervention had no significant effect on postural balance or other outcomes, but the wide range of adherence and a limited sample size challenged the robustness of these conclusions. Future work should increase focus on improving adherence to digital interventions. Trial Registration: ClinicalTrials.gov NCT04364243; https://clinicaltrials.gov/ct2/show/NCT04364243 International Registered Report Identifier (IRRID): RR2-10.2196/26982 UR - https://games.jmir.org/2022/2/e31685 UR - http://dx.doi.org/10.2196/31685 UR - http://www.ncbi.nlm.nih.gov/pubmed/35687390 ID - info:doi/10.2196/31685 ER - TY - JOUR AU - Agnew, R. Jonathon M. AU - Nugent, Chris AU - Hanratty, E. Catherine AU - Martin, Elizabeth AU - Kerr, P. Daniel AU - McVeigh, G. Joseph PY - 2022/5/26 TI - Rating the Quality of Smartphone Apps Related to Shoulder Pain: Systematic Search and Evaluation Using the Mobile App Rating Scale JO - JMIR Form Res SP - e34339 VL - 6 IS - 5 KW - mobile app KW - shoulder pain KW - mHealth KW - Mobile App Rating Scale KW - mobile phone N2 - Background: The successful rehabilitation of musculoskeletal pain requires more than medical input alone. Conservative treatment, including physiotherapy and exercise therapy, can be an effective way of decreasing pain associated with musculoskeletal pain. However, face-to-face appointments are currently not feasible. New mobile technologies, such as mobile health technologies in the form of an app for smartphones, can be a solution to this problem. In many cases, these apps are not backed by scientific literature. Therefore, it is important that they are reviewed and quality assessed. Objective: The aim is to evaluate and measure the quality of apps related to shoulder pain by using the Mobile App Rating Scale. Methods: This study included 25 free and paid apps?8 from the Apple Store and 17 from the Google Play Store. A total of 5 reviewers were involved in the evaluation process. A descriptive analysis of the Mobile App Rating Scale results provided a general overview of the quality of the apps. Results: Overall, app quality was generally low, with an average star rating of 1.97 out of 5. The best scores were in the ?Functionality? and ?Aesthetics? sections, and apps were scored poorer in the ?Engagement? and ?Information? sections. The apps were also rated poorly in the ?Subjective Quality? section. Conclusions: In general, the apps were well built technically and were aesthetically pleasing. However, the apps failed to provide quality information to users, which resulted in a lack of engagement. Most of the apps were not backed by scientific literature (24/25, 96%), and those that contained scientific references were vastly out-of-date. Future apps would need to address these concerns while taking simple measures to ensure quality control. UR - https://formative.jmir.org/2022/5/e34339 UR - http://dx.doi.org/10.2196/34339 UR - http://www.ncbi.nlm.nih.gov/pubmed/35617008 ID - info:doi/10.2196/34339 ER - TY - JOUR AU - Sweeney, Louise AU - Windgassen, Sula AU - Artom, Micol AU - Norton, Christine AU - Fawson, Sophie AU - Moss-Morris, Rona PY - 2022/5/18 TI - A Novel Digital Self-management Intervention for Symptoms of Fatigue, Pain, and Urgency in Inflammatory Bowel Disease: Describing the Process of Development JO - JMIR Form Res SP - e33001 VL - 6 IS - 5 KW - inflammatory bowel disease KW - symptoms KW - self-management KW - intervention development KW - digital health N2 - Background: Empirical studies and systematic reviews have demonstrated the role of biological, cognitive, behavioral, and emotional factors in fatigue, pain, and urgency in inflammatory bowel disease (IBD). Behavioral management that addresses the cognitive, behavioral, and emotional factors offered alongside medical treatment is seldom available to people with IBD. Digital interventions provide a potentially scalable and cost-effective way of providing behavioral support to patients. Objective: This paper aimed to describe the process of developing a supported digital self-management intervention for fatigue, pain, and urgency in IBD using theory and evidence-based approaches and stakeholder input. Methods: The Medical Research Council framework for complex health interventions and a person-based approach were used to guide intervention development, consulting with 87 patients with IBD and 60 nurses. These frameworks informed the selection and use of a theoretical model that subsequently guided cognitive behaviorally based intervention content. They also guided the design of tailored digital intervention pathways for individuals with IBD that matched the predominant symptoms. Results: A transsymptomatic cognitive behavioral framework of symptom perpetuation was developed for the symptoms of fatigue, pain, and urgency in IBD. A logic model was used to define the intervention techniques. Patient feedback and qualitative interviews refined the website content and functionalities, including the use of visual aids, email reminders, and graphical tracking of symptoms. Nurse focus groups informed the volume and delivery model of the therapist facilitator support. Ratings of acceptability out of 10 following feasibility testing (31/87, 36%) demonstrated accessibility (scoring 9.43, SD 1.040), ease (scoring 8.07, SD 3.205), clarity, and the relevant tone of the intervention. The final intervention comprised 12 web-based sessions (8 core and 4 symptom-specific), with one 30-minute facilitator phone call following session 1 and subsequent on-site messaging. Conclusions: The use of theory and integration of stakeholders? views throughout informed the development of an evidence-based digital intervention for fatigue, pain, and urgency in IBD. This is the first web-based self-management intervention designed to address these multiple symptoms with the aim of improving the quality of life and reducing the symptom burden of IBD. The intervention is being tested in a large multicenter randomized controlled trial. Trial Registration: ISRCTN Registry ISRCTN71618461; https://www.isrctn.com/ISRCTN71618461 UR - https://formative.jmir.org/2022/5/e33001 UR - http://dx.doi.org/10.2196/33001 UR - http://www.ncbi.nlm.nih.gov/pubmed/35583924 ID - info:doi/10.2196/33001 ER - TY - JOUR AU - Morcillo-Muñoz, Yolanda AU - Sánchez-Guarnido, José Antonio AU - Calzón-Fernández, Silvia AU - Baena-Parejo, Isabel PY - 2022/5/11 TI - Multimodal Chronic Pain Therapy for Adults via Smartphone: Randomized Controlled Clinical Trial JO - J Med Internet Res SP - e36114 VL - 24 IS - 5 KW - chronic pain KW - eHealth KW - multimodal intervention KW - catastrophizing KW - self-management KW - mHealth KW - mobile phone KW - randomized controlled trials N2 - Background: Combination therapies delivered remotely via the internet or mobile devices are increasingly being used to improve and promote the self-management of chronic conditions. However, little is known regarding the long-term effects of these interventions. Objective: The aim of this study is to evaluate the effectiveness of a multimodal intervention program that measures associated variables such as catastrophizing, pain acceptance, and quality of life using a mobile device in people with chronic pain in an outpatient setting. Methods: A randomized controlled clinical trial was performed using parallel treatment groups. A total of 209 patients with chronic musculoskeletal pain were randomly assigned to one of the two study arms. The intervention group received a standard web-based psychosocial therapy-type program of activities through a smartphone for 6 weeks. The control group only had access to the Find out more section of the app, which contained audiovisual material for pain management based on a self-help approach. The primary outcome was catastrophizing measured using the Pain Catastrophizing Scale (PCS). Secondary outcomes were pain acceptance measured using the Chronic Pain Acceptance Questionnaire and health-related quality of life measured using the EuroQol Visual Analogue Scale. Assessments were conducted at baseline (T1), after treatment (T2), and at the 3-month follow-up (T3). The variations between the different phases were assessed using the percentage change rescaled with log base 2. The Cohen d was calculated based on the results of the linear mixed model. The investigators of the study who evaluated the results were not involved in patient recruitment and were blinded to the group assignment. Results: Positive effects were found in the intervention group (T2?T1) in catastrophizing between the baseline and posttreatment phases (P<.001) and in helplessness (?0.72 vs 0.1; P=.002), rumination (?1.59 vs ?0.53; P<.001), acceptance (0.38 vs 0.05; P=.001), and quality of life (0.43 vs ?0.01; P=.002), although no significant changes were found for magnification (0.2 vs 0.77; P=.14) and satisfaction with health (0.25 vs ?0.27; P=.13). Three months after treatment, significant differences were observed in the intervention group for the outcome variable of catastrophizing (PCS; ?0.59 vs 0.2; P=.006) and the PCS subscales of helplessness (?0.65 vs 0.01; P=.07), rumination (1.23 vs ?0.59; P=.04), and magnification (0.1 vs 0.86; P=.02). Conclusions: The results of our study suggest that app-based mobile multidimensional treatments for adults with chronic pain improve catastrophizing, quality of life, and psychological flexibility immediately after treatment and that the effects are maintained for the primary outcome of catastrophizing for at least 3 months following treatment. Moreover, they promote self-management and can be used to complement face-to-face pain treatments. Trial Registration: ClinicalTrials.gov NCT04509154; https://clinicaltrials.gov/ct2/show/NCT04509154 UR - https://www.jmir.org/2022/5/e36114 UR - http://dx.doi.org/10.2196/36114 UR - http://www.ncbi.nlm.nih.gov/pubmed/35373 ID - info:doi/10.2196/36114 ER - TY - JOUR AU - Goudman, Lisa AU - Jansen, Julie AU - Billot, Maxime AU - Vets, Nieke AU - De Smedt, Ann AU - Roulaud, Manuel AU - Rigoard, Philippe AU - Moens, Maarten PY - 2022/5/10 TI - Virtual Reality Applications in Chronic Pain Management: Systematic Review and Meta-analysis JO - JMIR Serious Games SP - e34402 VL - 10 IS - 2 KW - virtual reality KW - chronic pain KW - systematic review KW - multilevel meta-analysis KW - immersive technologies KW - clinical outcomes KW - mobile phone N2 - Background: Virtual reality (VR) is a computer technology that immerses a user in a completely different reality. The application of VR in acute pain settings is well established. However, in chronic pain, the applications and outcome parameters influenced by VR are less clear. Objective: This review aimed to systematically identify all outcome parameters that are reported in relation to VR in patients with chronic pain. Methods: A total of 4 electronic databases (PubMed, Scopus, Web of Science, and Embase) were searched for relevant studies. Multilevel random-effect meta-analyses were performed, whereby the standardized mean difference was chosen as the effect size to denote the difference between measurements before and after a VR intervention. Results: The initial database search identified 1430 studies, of which 41 (2.87%) were eventually included in the systematic review. Evidence has been found for the effects of VR on pain, functioning, mobility, functional capacity, psychological outcomes, quality of life, neuropsychological outcomes, and physical sensations. The overall effect size (a total of 194 effect sizes from 25 studies) based on a three level meta-analysis was estimated at 1.22 (95% CI 0.55-1.89; z=3.56; P<.001), in favor of improvements after a VR intervention. When categorizing effect sizes, the overall effect sizes were reported as follows: 1.60 (95% CI 0.83-2.36; z=4.09; P<.001) for the effect of VR on pain (n=31), 1.40 (95% CI 0.13-2.67; z=2.17; P=.03) for functioning (n=60), 0.49 (95% CI ?0.71 to 1.68; z=0.80; P=.42) for mobility (n=24), and 0.34 (95% CI ?1.52 to 2.20; z=0.36; P=.72) for functional capacity (n=21). Conclusions: This systematic review revealed a broad range of outcome variables influenced by an intervention of VR technology, with statistically significant pain relief and improvements in functioning. These findings indicate that VR not only has applications in acute pain management but also in chronic pain settings, whereby VR might be able to become a promising first-line intervention as complementary therapy for patients with chronic pain. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42021227016; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=227016 UR - https://games.jmir.org/2022/2/e34402 UR - http://dx.doi.org/10.2196/34402 UR - http://www.ncbi.nlm.nih.gov/pubmed/35536641 ID - info:doi/10.2196/34402 ER - TY - JOUR AU - Tagwerker, Christian AU - Carias-Marines, Jane Mary AU - Smith, J. David PY - 2022/5/3 TI - Effects of Pharmacogenomic Testing in Clinical Pain Management: Retrospective Study JO - JMIRx Med SP - e32902 VL - 3 IS - 2 KW - pharmacogenomics KW - pain management KW - drug-drug interaction KW - DDI KW - pharmacy KW - prescriptions KW - genetics KW - genomics KW - drug-gene interaction KW - pain N2 - Background: The availability of pharmacogenomic (PGx) methods to determine the right drug and dosage for individualized patient treatment has increased over the past decade. Adoption of the resulting PGx reports in a clinical setting and monitoring of clinical outcomes is a challenging and long-term commitment. Objective: This study summarizes an extended PGx deep sequencing panel intended for medication dosing and prescription guidance newly adopted in a pain management clinic. The primary outcome of this retrospective study reports the number of cases and types of drugs covered, for which PGx data appears to have assisted in optimal drug prescription and dosing. Methods: A PGx panel is described, encompassing 23 genes and 141 single-nucleotide polymorphisms or indels, combined with PGx dosing guidance and drug-gene interaction (DGI) and drug-drug interaction (DDI) reporting to prevent adverse drug reactions (ADRs). During a 2-year period, patients (N=171) were monitored in a pain management clinic. Urine toxicology, PGx reports, and progress notes were studied retrospectively for changes in prescription regimens before and after the PGx report was made available to the provider. An additional algorithm provided DGIs and DDIs to prevent ADRs. Results: Among patient PGx reports with medication lists provided (n=146), 57.5% (n=84) showed one or more moderate and 5.5% (n=8) at least one serious PGx interaction. A total of 96 (65.8%) patients showed at least one moderate and 15.1% (n=22) one or more serious DGIs or DDIs. A significant number of active changes in prescriptions based on the 102 PGx/DGI/DDI report results provided was observed for 85 (83.3%) patients for which a specific drug was either discontinued or switched within the defined drug classes of the report, or a new drug was added. Conclusions: Preventative action was observed for all serious interactions, and only moderate interactions were tolerated for the lack of other alternatives. This study demonstrates the application of an extended PGx panel combined with a customized informational report to prevent ADRs and improve patient care. UR - https://med.jmirx.org/2022/2/e32902 UR - http://dx.doi.org/10.2196/32902 UR - http://www.ncbi.nlm.nih.gov/pubmed/37725552 ID - info:doi/10.2196/32902 ER - TY - JOUR AU - Wiklund, Tobias AU - Molander, Peter AU - Lindner, Philip AU - Andersson, Gerhard AU - Gerdle, Björn AU - Dragioti, Elena PY - 2022/4/29 TI - Internet-Delivered Cognitive Behavioral Therapy for Insomnia Comorbid With Chronic Pain: Randomized Controlled Trial JO - J Med Internet Res SP - e29258 VL - 24 IS - 4 KW - insomnia KW - chronic pain KW - comorbid KW - CBT-i KW - RCT KW - web-based CBT KW - pain KW - online health KW - online treatment KW - digital health KW - mental health KW - rehabilitation N2 - Background: Patients with chronic pain often experience insomnia symptoms. Pain initiates, maintains, and exacerbates insomnia symptoms, and vice versa, indicating a complex situation with an additional burden for these patients. Hence, the evaluation of insomnia-related interventions for patients with chronic pain is important. Objective: This randomized controlled trial examined the effectiveness of internet-based cognitive behavioral therapy for insomnia (ICBT-i) for reducing insomnia severity and other sleep- and pain-related parameters in patients with chronic pain. Participants were recruited from the Swedish Quality Registry for Pain Rehabilitation. Methods: We included 54 patients (mean age 49.3, SD 12.3 years) who were randomly assigned to the ICBT-i condition and 24 to an active control condition (applied relaxation). Both treatment conditions were delivered via the internet. The Insomnia Severity Index (ISI), a sleep diary, and a battery of anxiety, depression, and pain-related parameter measurements were assessed at baseline, after treatment, and at a 6-month follow-up (only ISI, anxiety, depression, and pain-related parameters). For the ISI and sleep diary, we also recorded weekly measurements during the 5-week treatment. Negative effects were also monitored and reported. Results: Results showed a significant immediate interaction effect (time by treatment) on the ISI and other sleep parameters, namely, sleep efficiency, sleep onset latency, early morning awakenings, and wake time after sleep onset. Participants in the applied relaxation group reported no significant immediate improvements, but both groups exhibited a time effect for anxiety and depression at the 6-month follow-up. No significant improvements on pain-related parameters were found. At the 6-month follow-up, both the ICBT-i and applied relaxation groups had similar sleep parameters. For both treatment arms, increased stress was the most frequently reported negative effect. Conclusions: In patients with chronic pain, brief ICBT-i leads to a more rapid decline in insomnia symptoms than does applied relaxation. As these results are unique, further research is needed to investigate the effect of ICBT-i on a larger sample size of people with chronic pain. Using both treatments might lead to an even better outcome in patients with comorbid insomnia and chronic pain. Trial Registration: ClinicalTrials.gov NCT03425942; https://clinicaltrials.gov/ct2/show/NCT03425942 UR - https://www.jmir.org/2022/4/e29258 UR - http://dx.doi.org/10.2196/29258 UR - http://www.ncbi.nlm.nih.gov/pubmed/35486418 ID - info:doi/10.2196/29258 ER - TY - JOUR AU - Meheli, Saha AU - Sinha, Chaitali AU - Kadaba, Madhura PY - 2022/4/27 TI - Understanding People With Chronic Pain Who Use a Cognitive Behavioral Therapy?Based Artificial Intelligence Mental Health App (Wysa): Mixed Methods Retrospective Observational Study JO - JMIR Hum Factors SP - e35671 VL - 9 IS - 2 KW - chronic pain KW - digital mental health KW - mobile health KW - mHealth KW - pain management KW - artificial intelligence KW - cognitive behavioral therapy KW - conversational agent KW - software agent KW - pain conditions KW - depression KW - anxiety N2 - Background: Digital health interventions can bridge barriers in access to treatment among individuals with chronic pain. Objective: This study aimed to evaluate the perceived needs, engagement, and effectiveness of the mental health app Wysa with regard to mental health outcomes among real-world users who reported chronic pain and engaged with the app for support. Methods: Real-world data from users (N=2194) who reported chronic pain and associated health conditions in their conversations with the mental health app were examined using a mixed methods retrospective observational study. An inductive thematic analysis was used to analyze the conversational data of users with chronic pain to assess perceived needs, along with comparative macro-analyses of conversational flows to capture engagement within the app. Additionally, the scores from a subset of users who completed a set of pre-post assessment questionnaires, namely Patient Health Questionnaire-9 (PHQ-9) (n=69) and Generalized Anxiety Disorder Assessment-7 (GAD-7) (n=57), were examined to evaluate the effectiveness of Wysa in providing support for mental health concerns among those managing chronic pain. Results: The themes emerging from the conversations of users with chronic pain included health concerns, socioeconomic concerns, and pain management concerns. Findings from the quantitative analysis indicated that users with chronic pain showed significantly greater app engagement (P<.001) than users without chronic pain, with a large effect size (Vargha and Delaney A=0.76-0.80). Furthermore, users with pre-post assessments during the study period were found to have significant improvements in group means for both PHQ-9 and GAD-7 symptom scores, with a medium effect size (Cohen d=0.60-0.61). Conclusions: The findings indicate that users look for tools that can help them address their concerns related to mental health, pain management, and sleep issues. The study findings also indicate the breadth of the needs of users with chronic pain and the lack of support structures, and suggest that Wysa can provide effective support to bridge the gap. UR - https://humanfactors.jmir.org/2022/2/e35671 UR - http://dx.doi.org/10.2196/35671 UR - http://www.ncbi.nlm.nih.gov/pubmed/35314422 ID - info:doi/10.2196/35671 ER - TY - JOUR AU - Jalilian, Laleh AU - Wu, Irene AU - Ing, Jakun AU - Dong, Xuezhi AU - Sadik, Joshua AU - Pan, George AU - Hitson, Heather AU - Thomas, Erin AU - Grogan, Tristan AU - Simkovic, Michael AU - Kamdar, Nirav PY - 2022/4/27 TI - Evaluation of Telemedicine Use for Anesthesiology Pain Division: Retrospective, Observational Case Series Study JO - JMIR Perioper Med SP - e33926 VL - 5 IS - 1 KW - COVID-19 KW - pain management KW - telemedicine KW - cost savings KW - patient satisfaction N2 - Background: An increasing number of patients require outpatient and interventional pain management. To help meet the rising demand for anesthesia pain subspecialty care in rural and metropolitan areas, health care providers have used telemedicine for pain management of both interventional patients and those with chronic pain. Objective: In this study, we aimed to describe the implementation of a telemedicine program for pain management in an academic pain division in a large metropolitan area. We also aimed to estimate patient cost savings from telemedicine, before and after the California COVID-19 ?Safer at Home? directive, and to estimate patient satisfaction with telemedicine for pain management care. Methods: This was a retrospective, observational case series study of telemedicine use in a pain division at an urban academic medical center. From August 2019 to June 2020, we evaluated 1398 patients and conducted 2948 video visits for remote pain management care. We used the publicly available Internal Revenue Service?s Statistics of Income data to estimate hourly earnings by zip code in order to estimate patient cost savings. We estimated median travel time and travel distance with Google Maps? Distance Matrix application programming interface, direct cost of travel with median value for regular fuel cost in California, and time-based opportunity savings from estimated hourly earnings and round-trip time. We reported patient satisfaction scores derived from a postvisit satisfaction survey containing questions with responses on a 5-point Likert scale. Results: Patients who attended telemedicine visits avoided an estimated median round-trip driving distance of 26 miles and a median travel time of 69 minutes during afternoon traffic conditions. Within the sample, their median hourly earnings were US $28 (IQR US $21-$39) per hour. Patients saved a median of US $22 on gas and parking and a median total of US $52 (IQR US $36-$75) per telemedicine visit based on estimated hourly earnings and travel time. Patients who were evaluated serially with telemedicine for medication management saved a median of US $156 over a median of 3 visits. A total of 91.4% (286/313) of patients surveyed were satisfied with their telemedicine experience. Conclusions: Telemedicine use for pain management reduced travel distance, travel time, and travel and time-based opportunity costs for patients with pain. We achieved the successful implementation of telemedicine across a pain division in an urban academic medical center with high patient satisfaction and patient cost savings. UR - https://periop.jmir.org/2022/1/e33926 UR - http://dx.doi.org/10.2196/33926 UR - http://www.ncbi.nlm.nih.gov/pubmed/35023841 ID - info:doi/10.2196/33926 ER - TY - JOUR AU - Hoag, A. Jennifer AU - Karst, Jeffrey AU - Bingen, Kristin AU - Palou-Torres, Akasha AU - Yan, Ke PY - 2022/4/18 TI - Distracting Through Procedural Pain and Distress Using Virtual Reality and Guided Imagery in Pediatric, Adolescent, and Young Adult Patients: Randomized Controlled Trial JO - J Med Internet Res SP - e30260 VL - 24 IS - 4 KW - virtual reality KW - procedural KW - pain KW - anxiety KW - pediatric KW - guided imagery N2 - Background: Children with acute and chronic illness undergo frequent, painful, and distressing procedures. Objective: This randomized controlled trial was used to evaluate the effectiveness of guided imagery (GI) versus virtual reality (VR) on the procedural pain and state anxiety of children and young adults undergoing unsedated procedures. We explored the role of trait anxiety and pain catastrophizing in intervention response. Methods: Children and young adults were recruited from the hematology, oncology, and blood and marrow transplant clinics at a children?s hospital. Each study participant completed the GI and VR intervention during separate but consecutive unsedated procedures. Self-report measures of pain and anxiety were completed before and after the procedures. Results: A total of 50 participants (median age 13 years) completed both interventions. GI and VR performed similarly in the management of procedural pain. Those with high pain catastrophizing reported experiencing less nervousness about pain during procedures that used VR than those using GI. State anxiety declined pre- to postprocedure in both interventions; however, the decrease reached the level of significance during the VR intervention only. Those with high trait anxiety had less pain during GI. Conclusions: In our sample, VR worked as well as GI to manage the pain and distress associated with common procedures experienced by children with acute or chronic illnesses. Children who are primed for pain based on beliefs about pain or because of their history of chronic pain had a better response to VR. GI was a better intervention for those with high trait anxiety. Trial Registration: ClinicalTrials.gov NCT04892160; https://clinicaltrials.gov/ct2/show/NCT04892160 UR - https://www.jmir.org/2022/4/e30260 UR - http://dx.doi.org/10.2196/30260 UR - http://www.ncbi.nlm.nih.gov/pubmed/35436209 ID - info:doi/10.2196/30260 ER - TY - JOUR AU - Gupta, Megha AU - Malik, Tanya AU - Sinha, Chaitali PY - 2022/3/31 TI - Delivery of a Mental Health Intervention for Chronic Pain Through an Artificial Intelligence?Enabled App (Wysa): Protocol for a Prospective Pilot Study JO - JMIR Res Protoc SP - e36910 VL - 11 IS - 3 KW - chronic pain KW - AI-enabled mental health assistant KW - digital health intervention KW - mental health conversational agent KW - artificial intelligence KW - depression KW - mental health KW - anxiety KW - health care cost KW - conversational agent KW - chatbot KW - digital health N2 - Background: Patients with chronic pain often experience coexisting, long-term and debilitating mental health comorbidities such as depression and anxiety. Artificial intelligence?supported cognitive behavioral therapy (AI-CBT) interventions could offer cost-effective, accessible, and potentially effective resources to address this problem. However, there is not enough research conducted about the efficacy of AI-CBT interventions for chronic pain. Objective: This prospective cohort study aims to examine the efficacy and use of an AI-CBT intervention for chronic pain (Wysa for Chronic Pain app, Wysa Inc) using a conversational agent (with no human intervention). To the best of our knowledge, this is the first such study for chronic pain using a fully-automated, free-text?based conversational agent. Methods: Participants with self-reported chronic pain (n=500) will be recruited online on a rolling basis from April 2022 through posts on US-based internet communities within this prospective cohort. Informed consent is received from participants within the app, and the Wysa for Chronic Pain intervention is delivered remotely for 8 weeks. Outcome measures including a numeric pain rating scale and Patient-Reported Outcomes Measurement Information System?Pain Interference, Generalized Anxiety Disorder?7, and Patient Health Questionnaire?9 questionnaires administered to test the effectiveness of the intervention on reducing levels of pain interference, depression, and anxiety. The therapeutic alliance created with the conversational agent will be assessed through the Working Alliance Inventory?Short Revised instrument. Retention and use statistics will be observed for adherence and engagement. Results: The study will open for recruitment in April 2022, and data collection is expected to be completed by August 2022. The results for the primary outcomes are expected to be published by late 2022. Conclusions: Mental health conversational agents driven by artificial intelligence could be effective in helping patients with chronic pain learn to self-manage their pain and common comorbidities like depression and anxiety. The Wysa for Chronic Pain app is one such digital intervention that can potentially serve as a solution to the problems of affordability and scalability associated with interventions that include a human therapist. This prospective study examines the efficacy of the app as a treatment solution for chronic pain. It aims to inform future practices and digital mental health interventions for individuals with chronic pain. International Registered Report Identifier (IRRID): PRR1-10.2196/36910 UR - https://www.researchprotocols.org/2022/3/e36910 UR - http://dx.doi.org/10.2196/36910 UR - http://www.ncbi.nlm.nih.gov/pubmed/35314423 ID - info:doi/10.2196/36910 ER - TY - JOUR AU - Lee, M. Jennifer AU - Woon, Rex AU - Ramsum, Mandy AU - Halperin, S. Daniel AU - Jain, Roshini PY - 2022/3/23 TI - User Engagement and Assessment of Treatment Effectiveness in Patients Using a Novel Digital mHealth App During Spinal Cord Stimulation Screening Trials JO - JMIR eHum Factors SP - e35134 VL - 9 IS - 1 KW - spinal cord stimulation KW - SCS KW - chronic pain KW - digital health KW - smartphone app KW - mobile health KW - mHealth KW - smart device KW - digital application KW - application KW - app KW - spine N2 - Background: Patient outcomes and experience during a Spinal Cord Stimulation (SCS) screening trial can have a significant effect on whether to proceed with long-term, permanent implantation of an SCS device for the treatment of chronic pain. Enhancing the ability to track and assess patients during this initial trial evaluation offers the potential for improved understanding regarding the suitability of permanent device implantation as well as identification of the SCS-based neurostimulative modalities and parameters that may provide substantial analgesia in a patient-specific manner. Objective: In this report, we aimed to describe a preliminary, real-world assessment of a new, real time tracking, smart, device-based digital app used by patients with chronic pain undergoing trial screening for SCS therapy. Methods: This is a real-world, retrospective evaluation of 13,331 patients diagnosed with chronic pain who used the new ?mySCS? mobile app during an SCS screening trial. The app design is health insurance portability and accountability act (HIPAA)-compliant and compatible with most commercially available smartphones (eg, Apple, iPhone, and Android). The app enables tracking of user-inputted health-related responses (ie, pain relief, activity level, and sleep quality) in addition to personal trial goals and a summary of overall experience during the SCS trial. A deidentified, aggregate analysis of user engagement, user-submitted responses, and overall trial success was conducted. Results: When provided the opportunity, the percentage of users who engaged with the tracking app for ?50% of the time during their trial was found to be 64.43% (n=8589). Among the 13,331 patients who used the app, 58.24% (n=7764) entered a trial goal. Most patients underwent SCS screening with a trial duration of at least 7 days (n=7739, 58.05%). Of those patients who undertook a 7-day SCS trial, 62.30% (n=3456) engaged the app for 4 days or more. In addition, among all who submitted descriptive responses using the app, health-related improvements were reported by 77.84% (n=10,377) of patients who reached day 3 of the screening phase assessment and by 83.04% (n=11,070) of those who reached trial completion. A trial success rate of 91% was determined for those who used the app (versus 85% success rate for nonusers). Conclusions: Data from this initial, real-world examination of a mobile, digital-health?based tracking app (?mySCS?), as used during the SCS screening phase, demonstrate that substantial patient engagement can be achieved while also providing for the acquisition of more real time patient-outcome measures that may help facilitate improved SCS trial success. UR - https://humanfactors.jmir.org/2022/1/e35134 UR - http://dx.doi.org/10.2196/35134 UR - http://www.ncbi.nlm.nih.gov/pubmed/35167484 ID - info:doi/10.2196/35134 ER - TY - JOUR AU - Peebles, T. Alexander AU - van der Veen, Susanne AU - Stamenkovic, Alexander AU - France, R. Christopher AU - Pidcoe, E. Peter AU - Thomas, S. James PY - 2022/3/23 TI - A Virtual Reality Game Suite for Graded Rehabilitation in Patients With Low Back Pain and a High Fear of Movement: Within-Subject Comparative Study JO - JMIR Serious Games SP - e32027 VL - 10 IS - 1 KW - virtual reality KW - reaching KW - intervention KW - rehabilitation KW - exergaming KW - biomechanics KW - serious games KW - gamification KW - movement KW - physiotherapy KW - lumbar N2 - Background: Complex movement pathologies that are biopsychosocial in nature (eg, back pain) require a multidimensional approach for effective treatment. Virtual reality is a promising tool for rehabilitation, where therapeutic interventions can be gamified to promote and train specific movement behaviors while increasing enjoyment, engagement, and retention. We have previously created virtual reality?based tools to assess and promote lumbar excursion during reaching and functional gameplay tasks by manipulating the position of static and dynamic contact targets. Based on the framework of graded exposure rehabilitation, we have created a new virtual reality therapy aimed to alter movement speed while retaining the movement-promoting features of our other developments. Objective: This study aims to compare lumbar flexion excursion and velocity across our previous and newly developed virtual reality tools in a healthy control cohort. Methods: A total of 31 healthy participants (16 males, 15 females) took part in 3 gamified virtual reality therapies (ie, Reachality, Fishality, and Dodgeality), while whole-body 3D kinematics were collected at 100 Hz using a 14-camera motion capture system. Lumbar excursion, lumbar flexion velocity, and actual target impact location in the anterior and vertical direction were compared across each virtual reality task and between the 4 anthropometrically defined intended target impact locations using separate 2-way repeated measures analysis of variance models. Results: There was an interaction between game and impact height for each outcome (all P<.001). Post-hoc simple effects models revealed that lumbar excursion was reduced during Reachality and Fishality relative to that during Dodgeality for the 2 higher impact heights but was greater during Reachality than during Fishality and Dodgeality for the lowest impact height. Peak lumbar flexion velocity was greater during Dodgeality than during Fishality and Reachality across heights. Actual target impact locations during Dodgeality and Fishality were lower relative to those during Reachality at higher intended impact locations but higher at lower intended impact locations. Finally, actual target impact location was further in the anterior direction for Reachality compared to that for Fishality and for Fishality relative to that for Dodgeality. Conclusions: Lumbar flexion velocity was reduced during Fishality relative to that during Dodgeality and resembled velocity demands more similar to those for a self-paced reaching task (ie, Reachality). Additionally, lumbar motion and target impact location during Fishality were more similar to those during Reachality than to those during Dodgeality, which suggests that this new virtual reality game is an effective tool for shaping movement. These findings are encouraging for future research aimed at developing an individualized and graded virtual reality intervention for patients with low back pain and a high fear of movement. UR - https://games.jmir.org/2022/1/e32027 UR - http://dx.doi.org/10.2196/32027 UR - http://www.ncbi.nlm.nih.gov/pubmed/35319471 ID - info:doi/10.2196/32027 ER - TY - JOUR AU - Turesson, Christina AU - Liedberg, Gunilla AU - Björk, Mathilda PY - 2022/3/14 TI - Development of a Digital Support Application With Evidence-Based Content for Sustainable Return to Work for Persons With Chronic Pain and Their Employers: User-Centered Agile Design Approach JO - JMIR Hum Factors SP - e33571 VL - 9 IS - 1 KW - agile design process KW - chronic pain KW - digital support KW - eHealth KW - return to work KW - self-management KW - smartphone apps KW - user-centered design KW - mobile phone N2 - Background: Persons with chronic pain experience a lack of support after completing rehabilitation and the responsibility for the return-to-work (RTW) process is taken over by the employer. In addition, employers describe not knowing how to support their employees. Smartphone apps have been increasingly used for self-management, but there is a lack of available eHealth apps with evidence-based content providing digital support for persons with chronic pain and their employers when they return to work. Objective: This study aims to describe the development of a digital support application with evidence-based content that includes a biopsychosocial perspective on chronic pain for sustainable RTW for persons with chronic pain and their employers (SWEPPE [Sustainable Worker Digital Support for Persons With Chronic Pain and Their Employers]). Methods: A user-centered agile design approach was applied. The multidisciplinary project team consisted of health care researchers, a user representative, and a software team. A total of 2 reference groups of 7 persons with chronic pain and 4 employers participated in the development process and usability testing. Mixed methods were used for data collection. The design was revised using feedback from the reference groups. The content of SWEPPE was developed based on existing evidence and input from the reference groups. Results: The reference groups identified the following as important characteristics to include in SWEPPE: keeping users motivated, tracking health status and work situation, and following progress. SWEPPE was developed as a smartphone app for the persons with chronic pain and as a web application for their employers. SWEPPE consists of six modules: the action plan, daily self-rating, self-monitoring graphs, the coach, the library, and shared information with the employer. The employers found the following functions in SWEPPE to be the most useful: employees? goals related to RTW, barriers to RTW, support wanted from the employer, and the ability to follow employees? progress. The persons with chronic pain found the following functions in SWEPPE to be the most useful: setting a goal related to RTW, identifying barriers and strategies, and self-monitoring. Usability testing revealed that SWEPPE was safe, useful (ie, provided relevant information), logical, and easy to use with an appealing interface. Conclusions: This study reports the development of a digital support application for persons with chronic pain and their employers. SWEPPE fulfilled the need of support after an interdisciplinary pain rehabilitation program with useful functions such as setting a goal related to RTW, identification of barriers and strategies for RTW, self-monitoring, and sharing information between the employee and the employer. The user-centered agile design approach contributed to creating SWEPPE as a relevant and easy-to-use eHealth intervention. Further studies are needed to examine the effectiveness of SWEPPE in a clinical setting. UR - https://humanfactors.jmir.org/2022/1/e33571 UR - http://dx.doi.org/10.2196/33571 UR - http://www.ncbi.nlm.nih.gov/pubmed/35285814 ID - info:doi/10.2196/33571 ER - TY - JOUR AU - Kerckhove, Nicolas AU - Delage, Noémie AU - Cambier, Sébastien AU - Cantagrel, Nathalie AU - Serra, Eric AU - Marcaillou, Fabienne AU - Maindet, Caroline AU - Picard, Pascale AU - Martiné, Gaelle AU - Deleens, Rodrigue AU - Trouvin, Anne-Priscille AU - Fourel, Lauriane AU - Espagne-Dubreuilh, Gaelle AU - Douay, Ludovic AU - Foulon, Stéphane AU - Dufraisse, Bénédicte AU - Gov, Christian AU - Viel, Eric AU - Jedryka, François AU - Pouplin, Sophie AU - Lestrade, Cécile AU - Combe, Emmanuel AU - Perrot, Serge AU - Perocheau, Dominique AU - De Brisson, Valentine AU - Vergne-Salle, Pascale AU - Mertens, Patrick AU - Pereira, Bruno AU - Djiberou Mahamadou, Jalil Abdoul AU - Antoine, Violaine AU - Corteval, Alice AU - Eschalier, Alain AU - Dualé, Christian AU - Attal, Nadine AU - Authier, Nicolas PY - 2022/3/2 TI - eDOL mHealth App and Web Platform for Self-monitoring and Medical Follow-up of Patients With Chronic Pain: Observational Feasibility Study JO - JMIR Form Res SP - e30052 VL - 6 IS - 3 KW - mHealth KW - chronic pain KW - feasibility study KW - eHealth KW - self-monitoring N2 - Background: Chronic pain affects approximately 30% of the general population, severely degrades quality of life (especially in older adults) and professional life (inability or reduction in the ability to work and loss of employment), and leads to billions in additional health care costs. Moreover, available painkillers are old, with limited efficacy and can cause significant adverse effects. Thus, there is a need for innovation in the management of chronic pain. Better characterization of patients could help to identify the predictors of successful treatments, and thus, guide physicians in the initial choice of treatment and in the follow-up of their patients. Nevertheless, current assessments of patients with chronic pain provide only fragmentary data on painful daily experiences. Real-life monitoring of subjective and objective markers of chronic pain using mobile health (mHealth) programs can address this issue. Objective: We hypothesized that regular patient self-monitoring using an mHealth app would lead physicians to obtain deeper understanding and new insight into patients with chronic pain and that, for patients, regular self-monitoring using an mHealth app would play a positive therapeutic role and improve adherence to treatment. We aimed to evaluate the feasibility and acceptability of a new mHealth app called eDOL. Methods: We conducted an observational study to assess the feasibility and acceptability of the eDOL tool. Patients completed several questionnaires using the tool over a period of 2 weeks and repeated assessments weekly over a period of 3 months. Physicians saw their patients at a follow-up visit that took place at least 3 months after the inclusion visit. A composite criterion of the acceptability and feasibility of the eDOL tool was calculated after the completion of study using satisfaction surveys from both patients and physicians. Results: Data from 105 patients (of 133 who were included) were analyzed. The rate of adherence was 61.9% (65/105) after 3 months. The median acceptability score was 7 (out of 10) for both patients and physicians. There was a high rate of completion of the baseline questionnaires and assessments (mean 89.3%), and a low rate of completion of the follow-up questionnaires and assessments (63.8% (67/105) and 61.9% (65/105) respectively). We were also able to characterize subgroups of patients and determine a profile of those who adhered to eDOL. We obtained 4 clusters that differ from each other in their biopsychosocial characteristics. Cluster 4 corresponds to patients with more disabling chronic pain (daily impact and comorbidities) and vice versa for cluster 1. Conclusions: This work demonstrates that eDOL is highly feasible and acceptable for both patients with chronic pain and their physicians. It also shows that such a tool can integrate many parameters to ensure the detailed characterization of patients for future research works and pain management. Trial Registration: ClinicalTrial.gov NCT03931694; http://clinicaltrials.gov/ct2/show/NCT03931694 UR - https://formative.jmir.org/2022/3/e30052 UR - http://dx.doi.org/10.2196/30052 UR - http://www.ncbi.nlm.nih.gov/pubmed/35234654 ID - info:doi/10.2196/30052 ER - TY - JOUR AU - Gardner, Tania AU - Schultz, Regina AU - Haskelberg, Hila AU - Newby, M. Jill AU - Wheatley, Jane AU - Millard, Michael AU - Faux, G. Steven AU - Shiner, T. Christine PY - 2022/2/3 TI - The Effect of Adjunct Telephone Support on Adherence and Outcomes of the Reboot Online Pain Management Program: Randomized Controlled Trial JO - J Med Internet Res SP - e30880 VL - 24 IS - 2 KW - chronic pain KW - online pain management KW - telephone support KW - clinician guidance KW - adherence KW - digital health KW - eHealth KW - internet interventions KW - multidisciplinary N2 - Background: Internet-based treatment programs present a solution for providing access to pain management for those unable to access clinic-based multidisciplinary pain programs. Attrition from internet interventions is a common issue. Clinician-supported guidance can be an important feature in web-based interventions; however, the optimal level of therapist guidance and expertise required to improve adherence remains unclear. Objective: The aim of this study is to evaluate whether augmenting the existing Reboot Online program with telephone support by a clinician improves program adherence and effectiveness compared with the web-based program alone. Methods: A 2-armed, CONSORT (Consolidated Standards of Reporting Trials)?compliant, registered randomized controlled trial with one-to-one group allocation was conducted. It compared a web-based multidisciplinary pain management program, Reboot Online, combined with telephone support (n=44) with Reboot Online alone (n=45) as the control group. Participants were recruited through web-based social media and the This Way Up service provider network. The primary outcome for this study was adherence to the Reboot Online program. Adherence was quantified through three metrics: completion of the program, the number of participants who enrolled into the program, and the number of participants who commenced the program. Data on adherence were collected automatically through the This Way Up platform. Secondary measures of clinical effectiveness were also collected. Results: Reboot Online combined with telephone support had a positive effect on enrollment and commencement of the program compared with Reboot Online without telephone support. Significantly more participants from the Reboot Online plus telephone support group enrolled (41/44, 93%) into the course than those from the control group (35/45, 78%; ?21=4.2; P=.04). Furthermore, more participants from the intervention group commenced the course than those from the control group (40/44, 91% vs 27/45, 60%, respectively; ?21=11.4; P=.001). Of the participants enrolled in the intervention group, 43% (19/44) completed the course, and of those in the control group, 31% (14/45) completed the course. When considering the subgroup of those who commenced the program, there was no significant difference between the proportions of people who completed all 8 lessons in the intervention (19/40, 48%) and control groups (14/27, 52%; ?21=1.3; P=.24). The treatment efficacy on clinical outcome measures did not differ between the intervention and control groups. Conclusions: Telephone support improves participants? registration, program commencement, and engagement in the early phase of the internet intervention; however, it did not seem to have an impact on overall course completion or efficacy. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12619001076167; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12619001076167 UR - https://www.jmir.org/2022/2/e30880 UR - http://dx.doi.org/10.2196/30880 UR - http://www.ncbi.nlm.nih.gov/pubmed/35113021 ID - info:doi/10.2196/30880 ER - TY - JOUR AU - Butler, Sonia AU - Sculley, Dean AU - Santos, Derek AU - Fellas, Antoni AU - Gironès, Xavier AU - Singh-Grewal, Davinder AU - Coda, Andrea PY - 2022/2/2 TI - Effectiveness of eHealth and mHealth Interventions Supporting Children and Young People Living With Juvenile Idiopathic Arthritis: Systematic Review and Meta-analysis JO - J Med Internet Res SP - e30457 VL - 24 IS - 2 KW - eHealth KW - mobile health KW - mHealth KW - juvenile idiopathic arthritis KW - pediatric KW - effectiveness KW - pain KW - physical activity KW - health-related quality of life KW - self-management KW - education KW - mobile phone N2 - Background: Juvenile idiopathic arthritis (JIA) management aims to promote remission through timely, individualized, well-coordinated interdisciplinary care using a range of pharmacological, physical, psychological, and educational interventions. However, achieving this goal is workforce-intensive. Harnessing the burgeoning eHealth and mobile health (mHealth) interventions could be a resource-efficient way of supplementing JIA management. Objective: This systematic review aims to identify the eHealth and mHealth interventions that have been proven to be effective in supporting health outcomes for children and young people (aged 1-18 years) living with JIA. Methods: We systematically searched 15 databases (2018-2021). Studies were eligible if they considered children and young people (aged 1-18 years) diagnosed with JIA, an eHealth or mHealth intervention, any comparator, and health outcomes related to the used interventions. Independently, 2 reviewers screened the studies for inclusion and appraised the study quality using the Downs and Black (modified) checklist. Study outcomes were summarized using a narrative, descriptive method and, where possible, combined for a meta-analysis using a random-effects model. Results: Of the 301 studies identified in the search strategy, 15 (5%) fair-to-good?quality studies met the inclusion criteria, which identified 10 interventions for JIA (age 4-18.6 years). Of these 10 interventions, 5 (50%) supported symptom monitoring by capturing real-time data using health applications, electronic diaries, or web-based portals to monitor pain or health-related quality of life (HRQoL). Within individual studies, a preference was demonstrated for real-time pain monitoring over recall pain assessments because of a peak-end effect, improved time efficiency (P=.002), and meeting children?s and young people?s HRQoL needs (P<.001) during pediatric rheumatology consultations. Furthermore, 20% (2/10) of interventions supported physical activity promotion using a web-based program or a wearable activity tracker. The web-based program exhibited a moderate effect, which increased endurance time, physical activity levels, and moderate to vigorous physical activity (standardized mean difference [SMD] 0.60, SD 0.02-1.18; I2=79%; P=.04). The final 30% (3/10) of interventions supported self-management development through web-based programs, or apps, facilitating a small effect, reducing pain intensity (SMD ?0.14, 95% CI ?0.43 to 0.15; I2=53%; P=.33), and increasing disease knowledge and self-efficacy (SMD 0.30, 95% CI 0.03-0.56; I2=74%; P=.03). These results were not statistically significant. No effect was seen regarding pain interference, HRQoL, anxiety, depression, pain coping, disease activity, functional ability, or treatment adherence. Conclusions: Evidence that supports the inclusion of eHealth and mHealth interventions in JIA management is increasing. However, this evidence needs to be considered cautiously because of the small sample size, wide CIs, and moderate to high statistical heterogeneity. More rigorous research is needed on the longitudinal effects of real-time monitoring, web-based pediatric rheumatologist?children and young people interactions, the comparison among different self-management programs, and the use of wearable technologies as an objective measurement for monitoring physical activity before any recommendations that inform current practice can be given. UR - https://www.jmir.org/2022/2/e30457 UR - http://dx.doi.org/10.2196/30457 UR - http://www.ncbi.nlm.nih.gov/pubmed/35107431 ID - info:doi/10.2196/30457 ER - TY - JOUR AU - Beltran-Alacreu, Hector AU - Navarro-Fernández, Gonzalo AU - Godia-Lledó, Daniela AU - Graell-Pasarón, Lucas AU - Ramos-González, Álvaro AU - Raya, Rafael AU - Martin-Pintado Zugasti, Aitor AU - Fernandez-Carnero, Josue PY - 2022/2/1 TI - A Serious Game for Performing Task-Oriented Cervical Exercises Among Older Adult Patients With Chronic Neck Pain: Development, Suitability, and Crossover Pilot Study JO - JMIR Serious Games SP - e31404 VL - 10 IS - 1 KW - video games KW - neck pain KW - aged KW - virtual reality KW - exercise therapy KW - physical therapy modalities KW - technology N2 - Background: There is sparse research on the effectiveness of therapeutic exercise for the treatment of neck pain in older adult populations. Moreover, there is a lack of research on the use of serious games or virtual reality for the treatment of neck pain in this population. Objective: The primary aim of this study was to develop and assess the suitability of a serious game for performing task-oriented cervical exercises in patients with neck pain. Methods: A serious game was designed based on the key features identified by previous studies that designed serious video games for physical and cognitive rehabilitation or exercise. The game in this study was designed to provide an interactive scenario, with the main functionality of the software solution to control a virtual airplane to reach targets using head motions. At the end of the exercise, the application stores the targets reached and missed and the airplane?s trajectory. A crossover pilot study was carried out for preliminary evaluation of the suitability of the technology in the older adult population. Men and women over 65 years of age with chronic neck pain were included. Subjects were randomly assigned to two study arms; each arm consisted of a sequence of two 4-week treatments with an intermediate washout period of 4 weeks. The total study duration was 16 weeks due to a final follow-up measure 4 weeks after the end of all treatments. Treatment A consisted of the use of the serious game developed in this study, and treatment B consisted of conventional exercises. Subjects allocated to the A-B study arm received treatment A first, followed by treatment B, and vice versa in the B-A arm. The following variables were assessed: Suitability Evaluation Questionnaire (SEQ) scores, Visual Analog Scale scores, and the number of targets reached in the serious game. Results: A total of 18 subjects were assessed for eligibility. A total of 13 subjects, aged between 71 and 92 years (mean 81.85, SD 6.82), were finally included and completed the study protocol. The global mean SEQ score was 50.38 (SD 5.35) out of 65 points, showing good suitability of the serious game. Most patients considered the experience very enjoyable and ?real? in terms of the virtual environment and found the information provided to be clear. Also, they believed that the game could be very helpful for their rehabilitation. None of the patients felt any neck pain or discomfort when playing the game, and only 2 patients out of 13 (15%) reported some degree of dizziness, eye discomfort, or disorientation, which did not limit their capacity to finish the session. Conclusions: The serious game developed in this study showed good suitability for use in adults over 70 years of age with chronic neck pain. The game was a safe method for performing task-oriented cervical exercises, and patients reported very high levels of satisfaction and acceptance after the use of this technology. UR - https://games.jmir.org/2022/1/e31404 UR - http://dx.doi.org/10.2196/31404 UR - http://www.ncbi.nlm.nih.gov/pubmed/35103608 ID - info:doi/10.2196/31404 ER - TY - JOUR AU - Vermeir, F. Julie AU - White, J. Melanie AU - Johnson, Daniel AU - Crombez, Geert AU - Van Ryckeghem, L. Dimitri M. PY - 2022/1/27 TI - Gamified Web-Delivered Attentional Bias Modification Training for Adults With Chronic Pain: Protocol for a Randomized, Double-blind, Placebo-Controlled Trial JO - JMIR Res Protoc SP - e32359 VL - 11 IS - 1 KW - chronic pain KW - cognition KW - attentional bias KW - gamification KW - motivation KW - randomized controlled trial KW - web-based intervention KW - pain management KW - digital intervention KW - digital health N2 - Background: To date, research has found variable success in using attentional bias modification training (ABMT) procedures in pain samples. Several factors could contribute to these mixed findings, including boredom and low motivation. Indeed, training paradigms are repetitive, which can lead to disengagement and high dropout rates. A potential approach to overcoming some of these barriers is to attempt to increase motivation and engagement through gamification (ie, the use of game elements) of this procedure. To date, research has yet to explore the gamified format of ABMT for chronic pain and its potential for the transfer of benefits. Objective: The aim of this study is to investigate the effects of a gamified web-delivered ABMT intervention in a sample of adults with chronic pain via a randomized, double-blind, placebo-controlled trial. Methods: A total of 120 adults with chronic musculoskeletal pain, recruited from clinical (hospital outpatient waiting list) and nonclinical (wider community) settings, will be included in this randomized, double-blind, placebo-controlled, 3-arm trial. Participants will be randomly assigned to complete 6 web-based sessions of dot-probe nongamified sham control ABMT, nongamified standard ABMT, or gamified ABMT across a period of 3 weeks. Active ABMT conditions will aim to train attention away from pain-relevant words. Participant outcomes will be assessed at pretraining, during training, immediately after training, and at the 1-month follow-up. Primary outcomes include pain intensity, pain interference, and behavioral and self-reported engagement. Secondary outcomes include attentional bias for pain, anxiety, depression, interpretation bias for pain, and perceived improvement. Results: The ethical aspects of this research project have been approved by the human research ethics committees of the Royal Brisbane and Women?s Hospital (HREC/2020/QRBW/61743) and Queensland University of Technology (2000000395). Study recruitment commenced in August 2021 and is ongoing. Data collection and analysis are expected to be concluded by October 2022 and January 2023, respectively. Conclusions: This trial will be the first to evaluate the effects of gamification techniques in a pain ABMT intervention. The findings will provide important information on the potential therapeutic benefits of gamified pain ABMT programs, shed light on the motivational influences of certain game elements in the context of pain, and advance our understanding of chronic pain. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12620000803998; https://anzctr.org.au/ACTRN12620000803998.aspx International Registered Report Identifier (IRRID): PRR1-10.2196/32359 UR - https://www.researchprotocols.org/2022/1/e32359 UR - http://dx.doi.org/10.2196/32359 UR - http://www.ncbi.nlm.nih.gov/pubmed/35084344 ID - info:doi/10.2196/32359 ER - TY - JOUR AU - Hogan, P. Timothy AU - Etingen, Bella AU - McMahon, Nicholas AU - Bixler, R. Felicia AU - Am, Linda AU - Wacks, E. Rachel AU - Shimada, L. Stephanie AU - Reilly, D. Erin AU - Frisbee, L. Kathleen AU - Smith, M. Bridget PY - 2022/1/20 TI - Understanding Adoption and Preliminary Effectiveness of a Mobile App for Chronic Pain Management Among US Military Veterans: Pre-Post Mixed Methods Evaluation JO - JMIR Form Res SP - e33716 VL - 6 IS - 1 KW - mobile health applications KW - pain KW - veterans KW - usability N2 - Background: The Veterans Health Administration Pain Coach mobile health app was developed to support veterans with chronic pain. Objective: Our objective was to evaluate early user experiences with the Pain Coach app and preliminary impacts of app use on pain-related outcomes. Methods: Following a sequential, explanatory, mixed methods design, we mailed surveys to veterans at 2 time points with an outreach program in between and conducted semistructured interviews with a subsample of survey respondents. We analyzed survey data using descriptive statistics among veterans who completed both surveys and examined differences in key outcomes using paired samples t tests. We analyzed semistructured interview data using thematic analysis. Results: Of 1507 veterans invited and eligible to complete the baseline survey, we received responses from 393 (26.1%). These veterans received our outreach program; 236 (236/393, 60.1%) completed follow-up surveys. We conducted interviews with 10 app users and 10 nonusers. Among survey respondents, 10.2% (24/236) used Pain Coach, and 58% (14/24) reported it was easy to use, though interviews identified various app usability issues. Veterans who used Pain Coach reported greater pain self-efficacy (mean 23.1 vs mean 16.6; P=.01) and lower pain interference (mean 34.6 vs mean 31.8; P=.03) after (vs before) use. The most frequent reason veterans reported for not using the app was that their health care team had not discussed it with them (96/212, 45.3%). Conclusions: Our findings suggest that future efforts to increase adoption of Pain Coach and other mobile apps among veterans should include health care team endorsement. Our findings regarding the impact of Pain Coach use on outcomes warrant further study. UR - https://formative.jmir.org/2022/1/e33716 UR - http://dx.doi.org/10.2196/33716 UR - http://www.ncbi.nlm.nih.gov/pubmed/35049515 ID - info:doi/10.2196/33716 ER - TY - JOUR AU - Rao, Nema AU - Perdomo, Sophy AU - Jonassaint, Charles PY - 2022/1/7 TI - A Novel Method for Digital Pain Assessment Using Abstract Animations: Human-Centered Design Approach JO - JMIR Hum Factors SP - e27689 VL - 9 IS - 1 KW - pain KW - pain measurement KW - chronic pain KW - animations KW - mobile apps KW - human-centered design N2 - Background: Patients with chronic pain face several challenges in using clinical tools to help them monitor, understand, and make meaningful decisions about their pain conditions. Our group previously presented data on Painimation, a novel electronic tool for communicating and assessing pain. Objective: This paper describes the human-centered design and development approach (inspiration, ideation, and implementation) that led to the creation of Painimation. Methods: We planned an iterative and cyclical development process that included stakeholder engagement and feedback from users. Stakeholders included patients with acute and chronic pain, health care providers, and design students. Target users were adults with acute or chronic pain who needed clinical assessment and tracking of the course of their pain over time. Phase I (inspiration) consisted of empathizing with users, understanding how patients experience pain, and identifying the barriers to accurately expressing and assessing pain. This phase involved understanding how patients communicate pain symptoms to providers, as well as defining limitations of current models of clinical pain assessment tools. In Phase II (ideate) we conceptualized and evaluated different approaches to expressing and assessing pain. The most promising concept was developed through an iterative process that involved end users and stakeholders. In Phase III (implementation), based on stakeholder feedback from initial designs and prototypes of abstract pain animations (painimations), we incorporated all concepts to test a minimally viable product, a fully functioning pain assessment app. We then gathered feedback through an agile development process and applied this feedback to finalizing a testable version of the app that could ultimately be used in a pain clinic. Results: Engaging intended users and stakeholders in an iterative, human-centered design process identified 5 criteria that a pain assessment tool would need to meet to be effective in the medical setting. These criteria were used as guiding design principles to generate a series of pain assessment concept ideas. This human-centered approach generated 8 highly visual painimations that were found to be acceptable and useable for communicating pain with medical providers, by both patients with general pain and patients with sickle cell disease (SCD). While these initial steps continued refinement of the tool, further data are needed. Agile development will allow us to continue to incorporate precision medicine tools that are validated in the clinical research arena. Conclusions: A multiphase, human-centered design approach successfully resulted in the development of an innovation that has potential to improve the quality of medical care, particularly for underserved populations. The use of Painimation may especially benefit the medical care of minority populations with chronic and difficult-to-treat pain, such as adults with SCD. The insights generated from this study can be applied to the development of patient-reported outcomes tools that are more patient-centered, engaging, and effective. UR - https://humanfactors.jmir.org/2022/1/e27689 UR - http://dx.doi.org/10.2196/27689 UR - http://www.ncbi.nlm.nih.gov/pubmed/34994697 ID - info:doi/10.2196/27689 ER - TY - JOUR AU - Soares, Bruno AU - Fonseca, Raquel AU - Fonseca, Patrícia AU - Alves, Paulo PY - 2021/12/17 TI - Accuracy of Physical Assessment in Nursing for Cervical Spine Joint Pain and Stiffness: Pilot Study Protocol JO - JMIR Res Protoc SP - e31878 VL - 10 IS - 12 KW - nursing process KW - nursing assessment KW - pain KW - referred pain KW - range of motion KW - neck pain KW - stomatognathic system KW - viscerosomatic reflexes KW - cervical spine dysfunction N2 - Background: Cervical spine dysfunction is a condition with high personal, social, and economic impact worldwide. Although its etiology is described as multifactorial, there is a need for further clarification. The literature has demonstrated the anatomical, physiological, and pathophysiological relationship among the cervical spine, temporomandibular joint, and visceral system. To guide and contribute to the accuracy of the physical assessment performed by nurses, we will study the influence of the stomatognathic system and viscerosomatic reflexes on pain and joint stiffness of the cervical spine. Objective: The aim of this study is to describe a pilot study protocol to investigate the influence of the stomatognathic system and viscerosomatic reflexes on cervical structures. Methods: A pilot study with a quasi-experimental design was conducted with 50 volunteers from the university population of the Universidade Católica Portuguesa-Porto. We studied the influence of changes in the usual intercuspation, the occlusal deprogramming, and the pressure stimulus of the reflex skin region of the ilium/colon in the cervical spine. This study was divided into 2 phases. In the first phase, we performed the kinematic and pain analysis during the passive mobilization of the upper cervical spine using the Motion Capture System at the Motion Capture Laboratory at UCP-Porto and the Visual Analog Scale. In the second phase, we evaluated the pain threshold on palpation of the erector neck muscles and the structures of the stomatognathic system using algometry. The influence of viscerosomatic reflexes on the structures of the stomatognathic system was also analyzed. Results: Selection and preparation of the data collection site, acquisition of materials, constitution of the sample group and data collection were completed. The analysis of the results is being carried out. Conclusions: The data from this study will allow for the detection of the possible influence of the stomatognathic system and viscerosomatic reflexes on pain and range of motion of the upper cervical spine, providing data for future randomized studies. We have also identified potential limitations of this study. International Registered Report Identifier (IRRID): RR1-10.2196/31878 UR - https://www.researchprotocols.org/2021/12/e31878 UR - http://dx.doi.org/10.2196/31878 UR - http://www.ncbi.nlm.nih.gov/pubmed/34927588 ID - info:doi/10.2196/31878 ER - TY - JOUR AU - Taguchi, Kayoko AU - Numata, Noriko AU - Takanashi, Rieko AU - Takemura, Ryo AU - Yoshida, Tokiko AU - Kutsuzawa, Kana AU - Yoshimura, Kensuke AU - Nozaki-Taguchi, Natsuko AU - Ohtori, Seiji AU - Shimizu, Eiji PY - 2021/11/22 TI - Clinical Effectiveness and Cost-effectiveness of Videoconference-Based Integrated Cognitive Behavioral Therapy for Chronic Pain: Randomized Controlled Trial JO - J Med Internet Res SP - e30690 VL - 23 IS - 11 KW - cognitive behavioral therapy KW - chronic pain KW - medical economic evaluation KW - EQ-5D-5L KW - telemedicine N2 - Background: Cognitive behavioral therapy is known to improve the management of chronic pain. However, the components of this therapy are still being investigated and debated. Objective: This study aimed to examine the effectiveness of an integrated cognitive behavioral therapy program with new components (attention-shift, memory work, video feedback, and image training) delivered via videoconferencing. Methods: This study was unblinded and participants were recruited and assessed face-to-face in the outpatient department. We conducted a randomized controlled trial for chronic pain to compare 16 weekly videoconference-based cognitive behavioral therapy (vCBT) sessions provided by a therapist with treatment as usual (TAU). Thirty patients (age range, 22-75 years) with chronic pain were randomly assigned to either vCBT (n=15) or TAU (n=15). Patients were evaluated at week 1 (baseline), week 8 (midintervention), and week 16 (postintervention). The primary outcome was the change in pain intensity, which was recorded using the numerical rating scale at 16 weeks from the baseline. Secondary outcomes were pain severity and pain interference, which were assessed using the Brief Pain Inventory. Additionally, we evaluated disability, pain catastrophizing cognition, depression, anxiety, quality of life, and cost utility. Results: In the eligibility assessment, 30 patients were eventually randomized and enrolled; finally, 15 patients in the vCBT and 14 patients in the TAU group were analyzed. Although no significant difference was found between the 2 groups in terms of changes in pain intensity by the numerical rating scale scores at week 16 from baseline (P=.36), there was a significant improvement in the comprehensive evaluation of pain by total score of Brief Pain Inventory (?1.43, 95% CI ?2.49 to ?0.37, df=24; P=.01). Further, significant improvement was seen in pain interference by using the Brief Pain Inventory (?9.42, 95% CI ?14.47 to ?4.36, df=25; P=.001) and in disability by using the Pain Disability Assessment Scale (?1.95, 95% CI ?3.33 to ?0.56, df=24; P=.008) compared with TAU. As for the Medical Economic Evaluation, the incremental cost-effectiveness ratio for 1 year was estimated at 2.9 million yen (about US $25,000) per quality-adjusted life year gained. Conclusions: The findings of our study suggest that integrated cognitive behavioral therapy delivered by videoconferencing in regular medical care may reduce pain interference but not pain intensity. Further, this treatment method may be cost-effective, although this needs to be further verified using a larger sample size. Trial Registration: University Hospital Medical Information Network UMIN000031124; https://tinyurl.com/2pr3xszb UR - https://www.jmir.org/2021/11/e30690 UR - http://dx.doi.org/10.2196/30690 UR - http://www.ncbi.nlm.nih.gov/pubmed/34813489 ID - info:doi/10.2196/30690 ER - TY - JOUR AU - Afzali, Tamana AU - Lauridsen, Hein Henrik AU - Thomsen, Laust Janus AU - Hartvigsen, Jan AU - Jensen, Bach Martin AU - Riis, Allan PY - 2021/11/15 TI - The Online Patient Satisfaction Index for Patients With Low Back Pain: Development, Reliability, and Validation Study JO - JMIR Form Res SP - e21462 VL - 5 IS - 11 KW - data accuracy KW - patient satisfaction KW - rehabilitation KW - low back pain KW - internet-based intervention KW - mobile phone N2 - Background: Low back pain is highly prevalent, and most often, a specific causative factor cannot be identified. Therefore, for most patients, their low back pain is labeled as nonspecific. Patient education and information are recommended for all these patients. The internet is an accessible source of medical information on low back pain. Approximately 50% of patients with low back pain search the internet for health and medical advice. Patient satisfaction with education and information is important in relation to patients? levels of inclination to use web-based information and their trust in the information they find. Although patients who are satisfied with the information they retrieve use the internet as a supplementary source of information, dissatisfied patients tend to avoid using the internet. Consumers? loyalty to a product is often applied to evaluate their satisfaction. Consumers have been shown to be good ambassadors for a service when they are willing to recommend the service to a friend or colleague. When consumers are willing to recommend a service to a friend or colleague, they are also likely to be future users of the service. To the best of our knowledge, no multi-item instrument exists to specifically evaluate satisfaction with information delivered on the web for people with low back pain. Objective: This study aims to report on the development, reliability testing, and construct validity testing of the Online Patient Satisfaction Index to measure patients? satisfaction with web-based information for low back pain. Methods: This is a cross-sectional validation study of the Online Patient Satisfaction Index. The index was developed with experts and assessed for face validity. It was subsequently administered to 150 adults with nonspecific low back pain. Of these, 46% (70/150) were randomly assigned to participate in a reliability test using an intraclass correlation coefficient of agreement. Construct validity was evaluated by hypothesis testing based on a web app (MyBack) and Wikipedia on low back pain. Results: The index includes 8 items. The median score (range 0-24) based on the MyBack website was 20 (IQR 18-22), and the median score for Wikipedia was 12 (IQR 8-15). The entire score range was used. Overall, 53 participants completed a retest, of which 39 (74%) were stable in their satisfaction with the home page and were included in the analysis for reliability. Intraclass correlation coefficient of agreement was estimated to be 0.82 (95% CI 0.68-0.90). Two hypothesized correlations for construct validity were confirmed through an analysis using complete data. Conclusions: The index had good face validity, excellent reliability, and good construct validity and can be used to measure satisfaction with the provision of web-based information regarding nonspecific low back pain among people willing to access the internet to obtain health information. Trial Registration: ClinicalTrials.gov NCT03449004; https://clinicaltrials.gov/ct2/show/NCT03449004 UR - https://formative.jmir.org/2021/11/e21462 UR - http://dx.doi.org/10.2196/21462 UR - http://www.ncbi.nlm.nih.gov/pubmed/34779785 ID - info:doi/10.2196/21462 ER - TY - JOUR AU - Jain, Deeptee AU - Norman, Kevin AU - Werner, Zachary AU - Makovoz, Bar AU - Baker, Turner AU - Huber, Stephan PY - 2021/11/9 TI - Using Postmarket Surveillance to Assess Safety-Related Events in a Digital Rehabilitation App (Kaia App): Observational Study JO - JMIR Hum Factors SP - e25453 VL - 8 IS - 4 KW - lower back pain KW - digital therapeutics KW - adverse event KW - pain KW - safety KW - digital health KW - multidisciplinary pain treatment N2 - Background: Low back pain (LBP) affects nearly 4 out of 5 individuals during their lifetime and is the leading cause of disability globally. Digital therapeutics are emerging as effective treatment options for individuals experiencing LBP. Despite the growth of evidence demonstrating the benefits of these therapeutics in reducing LBP and improving functional outcomes, little data has been systematically collected on their safety profiles. Objective: This study aims to evaluate the safety profile of a multidisciplinary digital therapeutic for LBP, the Kaia App, by performing a comprehensive assessment of reported adverse events (AEs) by users as captured by a standardized process for postmarket surveillance. Methods: All users of a multidisciplinary digital app that includes physiotherapy, mindfulness techniques, and education for LBP (Kaia App) from 2018 to 2019 were included. Relevant messages sent by users via the app were collected according to a standard operating procedure regulating postmarket surveillance of the device. These messages were then analyzed to determine if they described an adverse event (AE). Messages describing an AE were then categorized based on the type of AE, its seriousness, and its relatedness to the app, and they were described by numerical counts. User demographics, including age and gender, and data on app use were collected and evaluated to determine if they were risk factors for increased AE reporting. Results: Of the 138,337 active users of the Kaia App, 125 (0.09%) reported at least one AE. Users reported 0.00014 AEs per active day on the app. The most common nonserious AE reported was increased pain. Other nonserious AEs reported included muscle issues, unpleasant sensations, headache, dizziness, and sleep disturbances. One serious AE, a surgery, was reported. Details of the event and its connection to the intervention were not obtainable, as the user did not provide more information when asked to do so; therefore, it was considered to be possibly related to the intervention. There was no relationship between gender and AE reporting (P>.99). Users aged 25 to 34 years had reduced odds (odds ratio [OR] 0.31, 95% CI 0.08-0.95; P=.03) of reporting AEs, while users aged 55 to 65 years (OR 2.53, 95% CI 1.36-4.84, P=.002) and ?75 years (OR 4.36, 95% CI 1.07-13.26; P=.02) had increased odds. AEs were most frequently reported by users who had 0 to 99 active days on the app, and less frequently reported by users with more active days on the app. Conclusions: This study on the Kaia App provides the first comprehensive assessment of reported AEs associated with real-world use of digital therapeutics for lower back pain. The overall rate of reported AEs was very low, but significant reporting bias is likely to be present. The AEs reported were generally consistent with those described for in-person therapies for LBP. UR - https://humanfactors.jmir.org/2021/4/e25453 UR - http://dx.doi.org/10.2196/25453 UR - http://www.ncbi.nlm.nih.gov/pubmed/34751664 ID - info:doi/10.2196/25453 ER - TY - JOUR AU - Nelligan, K. Rachel AU - Hinman, S. Rana AU - McManus, Fiona AU - Lamb, E. Karen AU - Bennell, L. Kim PY - 2021/10/29 TI - Moderators of the Effect of a Self-directed Digitally Delivered Exercise Program for People With Knee Osteoarthritis: Exploratory Analysis of a Randomized Controlled Trial JO - J Med Internet Res SP - e30768 VL - 23 IS - 10 KW - digital KW - text messaging KW - exercise KW - moderators KW - osteoarthritis KW - RCT KW - clinical trial KW - subgroups KW - pain KW - function KW - knee osteoarthritis KW - rehabilitation KW - digital health N2 - Background: A 24-week self-directed digitally delivered intervention was found to improve pain and function in people with knee osteoarthritis (OA). However, it is possible that this intervention may be better suited to certain subgroups of people with knee OA compared to others. Objective: The aim of this study was to explore whether certain individual baseline characteristics moderate the effects of a self-directed digitally delivered intervention on changes in pain and function over 24 weeks in people with knee OA. Methods: An exploratory analysis was conducted on data from a randomized controlled trial involving 206 people with a clinical diagnosis of knee OA. This trial compared a self-directed digitally delivered intervention comprising of web-based education, exercise, and physical activity program supported by automated exercise behavior change mobile phone text messages to web-based education alone (control). The primary outcomes were changes in overall knee pain (assessed on an 11-point numerical rating scale) and physical function (assessed using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale [WOMAC]) at 24 weeks. Five baseline patient characteristics were selected as the potential moderators: (1) number of comorbidities, (2) number of other painful joints, (3) pain self-efficacy, (4) exercise self-efficacy, and (5) self-perceived importance of exercise. Separate linear regression models for each primary outcome and each potential moderator were fit, including treatment group, moderator, and interaction between treatment group and moderator, adjusting for the outcome at baseline. Results: There was evidence that pain self-efficacy moderated the effect of the intervention on physical function compared to the control at 24 weeks (interaction P=.02). Posthoc assessment of the mean change in WOMAC function by treatment arm showed that each 1-unit increase in baseline pain self-efficacy was associated with a 1.52 (95% CI 0.27 to 2.78) unit improvement in the control group. In contrast, a reduction of 0.62 (95% CI ?1.93 to 0.68) units was observed in the intervention group with each unit increase in pain self-efficacy. There was only weak evidence that pain self-efficacy moderated the effect of the intervention on pain and that number of comorbidities, number of other painful joints, exercise self-efficacy, or exercise importance moderated the effect of the intervention on pain or function. Conclusions: With the exception of pain self-efficacy, which moderated changes in function but not pain, we found limited evidence that our selected baseline patient characteristics moderated intervention outcomes. This indicates that people with a range of baseline characteristics respond similarly to the unsupervised digitally delivered exercise intervention. As these findings are exploratory in nature, they require confirmation in future studies. UR - https://www.jmir.org/2021/10/e30768 UR - http://dx.doi.org/10.2196/30768 UR - http://www.ncbi.nlm.nih.gov/pubmed/34714252 ID - info:doi/10.2196/30768 ER - TY - JOUR AU - Hu, Xiao-Su AU - Beard, Katherine AU - Sherbel, Catherine Mary AU - Nascimento, D. Thiago AU - Petty, Sean AU - Pantzlaff, Eddie AU - Schwitzer, David AU - Kaciroti, Niko AU - Maslowski, Eric AU - Ashman, M. Lawrence AU - Feinberg, E. Stephen AU - DaSilva, F. Alexandre PY - 2021/10/12 TI - Brain Mechanisms of Virtual Reality Breathing Versus Traditional Mindful Breathing in Pain Modulation: Observational Functional Near-infrared Spectroscopy Study JO - J Med Internet Res SP - e27298 VL - 23 IS - 10 KW - virtual reality breathing KW - traditional mindful breathing KW - pain KW - functional near-infrared spectroscopy KW - mobile phone N2 - Background: Pain is a complex experience that involves sensory-discriminative and cognitive-emotional neuronal processes. It has long been known across cultures that pain can be relieved by mindful breathing (MB). There is a common assumption that MB exerts its analgesic effect through interoception. Interoception refers to consciously refocusing the mind?s attention to the physical sensation of internal organ function. Objective: In this study, we dissect the cortical analgesic processes by imaging the brains of healthy subjects exposed to traditional MB (TMB) and compare them with another group for which we augmented MB to an outside sensory experience via virtual reality breathing (VRB). Methods: The VRB protocol involved in-house?developed virtual reality 3D lungs that synchronized with the participants? breathing cycles in real time, providing them with an immersive visual-auditory exteroception of their breathing. Results: We found that both breathing interventions led to a significant increase in pain thresholds after week-long practices, as measured by a thermal quantitative sensory test. However, the underlying analgesic brain mechanisms were opposite, as revealed by functional near-infrared spectroscopy data. In the TMB practice, the anterior prefrontal cortex uniquely modulated the premotor cortex. This increased its functional connection with the primary somatosensory cortex (S1), thereby facilitating the S1-based sensory-interoceptive processing of breathing but inhibiting its other role in sensory-discriminative pain processing. In contrast, virtual reality induced an immersive 3D exteroception with augmented visual-auditory cortical activations, which diminished the functional connection with the S1 and consequently weakened the pain processing function of the S1. Conclusions: In summary, our study suggested two analgesic neuromechanisms of VRB and TMB practices?exteroception and interoception?that distinctively modulated the S1 processing of the ascending noxious inputs. This is in line with the concept of dualism (Yin and Yang). UR - https://www.jmir.org/2021/10/e27298 UR - http://dx.doi.org/10.2196/27298 UR - http://www.ncbi.nlm.nih.gov/pubmed/34636731 ID - info:doi/10.2196/27298 ER - TY - JOUR AU - Sarkar, Urmimala AU - Lee, E. Jane AU - Nguyen, H. Kim AU - Lisker, Sarah AU - Lyles, R. Courtney PY - 2021/9/22 TI - Barriers and Facilitators to the Implementation of Virtual Reality as a Pain Management Modality in Academic, Community, and Safety-Net Settings: Qualitative Analysis JO - J Med Internet Res SP - e26623 VL - 23 IS - 9 KW - virtual reality KW - medical informatics KW - information technology KW - implementation science KW - qualitative research N2 - Background: Prior studies have shown that virtual reality (VR) is an efficacious treatment modality for opioid-sparing pain management. However, the majority of these studies were conducted among primarily White, relatively advantaged populations and in well-resourced settings. Objective: We conducted a qualitative, theory-informed implementation science study to assess the readiness for VR in safety-net settings. Methods: Using the theoretical lens of the Consolidated Framework for Implementation Research (CFIR) framework, we conducted semistructured interviews with current VR users and nonusers based in safety-net health systems (n=15). We investigated barriers and facilitators to a commercially available, previously validated VR technology platform AppliedVR (Los Angeles, CA, USA). We used deductive qualitative analysis using the overarching domains of the CFIR framework and performed open, inductive coding to identify specific themes within each domain. Results: Interviewees deemed the VR intervention to be useful, scalable, and an appealing alternative to existing pain management approaches. Both users and nonusers identified a lack of reimbursement for VR as a significant challenge for adoption. Current users cited positive patient feedback, but safety-net stakeholders voiced concern that existing VR content may not be relevant or appealing to diverse patients. All respondents acknowledged the challenge of integrating and maintaining VR in current pain management workflows across a range of clinical settings, and this adoption challenge was particularly acute, given resource and staffing constraints in safety-net settings. Conclusions: VR for pain management holds interest for frontline pain management clinicians and leadership in safety-net health settings but will require significant tailoring and adaption to address the needs of diverse populations. Integration into complex workflows for pain management is a significant barrier to adoption, and participants cited structural cost and reimbursement concerns as impediments to initial implementation and scaling of VR use. UR - https://www.jmir.org/2021/9/e26623 UR - http://dx.doi.org/10.2196/26623 UR - http://www.ncbi.nlm.nih.gov/pubmed/34550074 ID - info:doi/10.2196/26623 ER - TY - JOUR AU - Ziadni, S. Maisa AU - Gonzalez-Castro, Lluvia AU - Anderson, Steven AU - Krishnamurthy, Parthasarathy AU - Darnall, D. Beth PY - 2021/9/10 TI - Efficacy of a Single-Session ?Empowered Relief? Zoom-Delivered Group Intervention for Chronic Pain: Randomized Controlled Trial Conducted During the COVID-19 Pandemic JO - J Med Internet Res SP - e29672 VL - 23 IS - 9 KW - single-session KW - empowered relief KW - Zoom-delivered KW - pain catastrophizing KW - pain intensity KW - randomized-controlled trial KW - chronic pain N2 - Background: Cognitive behavioral therapy?pain is an evidence-based treatment for chronic pain that can have significant patient burden, including health care cost, travel, multiple sessions, and lack of access in remote areas. Objective: The study aims to pilot test the efficacy of a single-session videoconference-delivered empowered relief (ER) intervention compared to waitlist control (WLC) conditions among individuals with chronic pain. We hypothesized that ER would be superior to WLC in reducing pain catastrophizing, pain intensity, and other pain-related outcomes at 1-3 months posttreatment. Methods: We conducted a randomized controlled trial involving a web-based sample of adults (N=104) aged 18-80 years with self-reported chronic pain. Participants were randomized (1:1) to 1 of 2 unblinded study groups: ER (50/104, 48.1%) and WLC (54/104, 51.9%). Participants allocated to ER completed a Zoom-delivered class, and all participants completed follow-up surveys at 2 weeks and 1, 2, and 3 months posttreatment. All the study procedures were performed remotely and electronically. The primary outcome was pain catastrophizing 1-month posttreatment, with pain intensity, pain bothersomeness, and sleep disruption as secondary outcomes. We also report a more rigorous test of the durability of treatment effects at 3 months posttreatment. Data were collected from September 2020 to February 2021 and analyzed using intention-to-treat analysis. The analytic data set included participants (18/101, 17.8% clinic patients; 83/101, 82.1% community) who completed at least one study survey: ER (50/101, 49.5%) and WLC (51/104, 49%). Results: Participants (N=101) were 69.3% (70/101) female, with a mean age of 49.76 years (SD 13.90; range 24-78); 32.7% (33/101) had an undergraduate degree and self-reported chronic pain for 3 months. Participants reported high engagement (47/50, 94%), high satisfaction with ER (mean 8.26, SD 1.57; range 0-10), and high satisfaction with the Zoom platform (46/50, 92%). For the between-groups factor, ER was superior to WLC for all primary and secondary outcomes at 3 months posttreatment (highest P<.001), and between-groups Cohen d effect sizes ranged from 0.45 to 0.79, indicating that the superiority was of moderate to substantial clinical importance. At 3 months, clinically meaningful pain catastrophizing scale (PCS) reductions were found for ER but not for WLC (ER: PCS ?8.72, 42.25% reduction; WLC: PCS ?2.25, 11.13% reduction). ER resulted in significant improvements in pain intensity, sleep disturbance, and clinical improvements in pain bothersomeness. Conclusions: Zoom-delivered ER had high participant satisfaction and very high engagement. Among adults with chronic pain, this single-session, Zoom-delivered, skills-based pain class resulted in clinically significant improvement across a range of pain-related outcomes that was sustained at 3 months. Web-based delivery of ER could allow greater accessibility of home-based pain treatment and could address the inconveniences and barriers faced by patients when attempting to receive in-person care. Trial Registration: ClinicalTrials.gov NCT04546685; https://clinicaltrials.gov/ct2/show/NCT04546685 UR - https://www.jmir.org/2021/9/e29672 UR - http://dx.doi.org/10.2196/29672 UR - http://www.ncbi.nlm.nih.gov/pubmed/34505832 ID - info:doi/10.2196/29672 ER - TY - JOUR AU - Martorella, Geraldine AU - Hanley, W. Adam AU - Pickett, M. Scott AU - Gelinas, Céline PY - 2021/8/30 TI - Web- and Mindfulness-Based Intervention to Prevent Chronic Pain After Cardiac Surgery: Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e30951 VL - 10 IS - 8 KW - postoperative pain KW - cardiac surgery KW - chronic pain KW - web-based KW - mindfulness KW - mobile phone N2 - Background: Cardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined. Objective: The aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery. Methods: A double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ?18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ?4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University?s Council on Research & Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board. Results: Recruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic. Conclusions: This research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain. International Registered Report Identifier (IRRID): DERR1-10.2196/30951 UR - https://www.researchprotocols.org/2021/8/e30951 UR - http://dx.doi.org/10.2196/30951 UR - http://www.ncbi.nlm.nih.gov/pubmed/34459749 ID - info:doi/10.2196/30951 ER - TY - JOUR AU - Shaballout, Nour AU - Aloumar, Anas AU - Manuel, Jorge AU - May, Marcus AU - Beissner, Florian PY - 2021/8/27 TI - Lateralization and Bodily Patterns of Segmental Signs and Spontaneous Pain in Acute Visceral Disease: Observational Study JO - J Med Internet Res SP - e27247 VL - 23 IS - 8 KW - digital pain drawings KW - visceral referred pain KW - referred pain KW - head zones KW - mydriasis KW - chest pain KW - clinical examination KW - differential diagnosis KW - digital health KW - digital drawings KW - pain KW - health technology KW - image analysis N2 - Background: The differential diagnosis of acute visceral diseases is a challenging clinical problem. Older literature suggests that patients with acute visceral problems show segmental signs such as hyperalgesia, skin resistance, or muscular defense as manifestations of referred visceral pain in somatic or visceral tissues with overlapping segmental innervation. According to these sources, the lateralization and segmental distribution of such signs may be used for differential diagnosis. Segmental signs and symptoms may be accompanied by spontaneous (visceral) pain, which, however, shows a nonsegmental distribution. Objective: This study aimed to investigate the lateralization (ie, localization on one side of the body, in preference to the other) and segmental distribution (ie, surface ratio of the affected segments) of spontaneous pain and (referred) segmental signs in acute visceral diseases using digital pain drawing technology. Methods: We recruited 208 emergency room patients that were presenting for acute medical problems considered by triage as related to internal organ disease. All patients underwent a structured 10-minute bodily examination to test for various segmental signs and spontaneous visceral pain. They were further asked their segmental symptoms such as nausea, meteorism, and urinary retention. We collected spontaneous pain and segmental signs as digital drawings and segmental symptoms as binary values on a tablet PC. After the final diagnosis, patients were divided into groups according to the organ affected. Using statistical image analysis, we calculated mean distributions of pain and segmental signs for the heart, lungs, stomach, liver/gallbladder, and kidneys/ureters, analyzing the segmental distribution of these signs and the lateralization. Results: Of the 208 recruited patients, 110 (52.9%) were later diagnosed with a single-organ problem. These recruited patients had a mean age of 57.3 (SD 17.2) years, and 40.9% (85/208) were female. Of these 110 patients, 85 (77.3%) reported spontaneous visceral pain. Of the 110, 81 (73.6%) had at least 1 segmental sign, and the most frequent signs were hyperalgesia (46/81, 57%), and muscle resistance (39/81, 48%). While pain was distributed along the body midline, segmental signs for the heart, stomach, and liver/gallbladder appeared mostly ipsilateral to the affected organ. An unexpectedly high number of patients (37/110, 33.6%) further showed ipsilateral mydriasis. Conclusions: This study underlines the usefulness of including digitally recorded segmental signs in bodily examinations of patients with acute medical problems. UR - https://www.jmir.org/2021/8/e27247 UR - http://dx.doi.org/10.2196/27247 UR - http://www.ncbi.nlm.nih.gov/pubmed/34448718 ID - info:doi/10.2196/27247 ER - TY - JOUR AU - Ledermann, Katharina AU - Abou Khaled, Omar AU - Caon, Maurizio AU - Berger, Thomas AU - Chabwine, N. Joelle AU - Wicht, Joachim AU - Martin-Soelch, Chantal PY - 2021/8/26 TI - An Ecological Monitoring and Management App (EMMA) for Older Adults With Chronic Pain: Protocol for a Design and Feasibility Study JO - JMIR Res Protoc SP - e26930 VL - 10 IS - 8 KW - chronic pain KW - older adults KW - mHealth KW - online intervention KW - self-management N2 - Background: Chronic pain is a complex problem for many older adults that affects both physical functioning and psychological well-being. Mobile health (mHealth) technologies have shown promise in supporting older persons in managing chronic conditions. Cognitive behavior therapy is recommended for older people with chronic pain. However, web-based treatment programs for chronic pain are not aimed at the needs of older people and offer standard therapies without providing tailored treatment for this population. Objective: To address this problem, we aim to develop a psychological web-based intervention for ecological monitoring of daily life experiences with chronic pain called EMMA to support self-management of chronic pain in older adults. Methods: The key clinical and engagement features of the intervention were established through the integration of evidence-based material from cognitive behavioral therapy for the treatment of chronic pain in older adults. The development process uses a co-design approach and actively involves end-users in the design process by incorporating feedback from focus groups with older adults in order to inform a user-centered intervention design. For the co-design process, we will include 10 older adults with chronic pain, who will discuss the requirements for the app in workshops in order to ensure suitability of the app for older adults with chronic pain. In order to test the feasibility and acceptability of the intervention, we will include a sample of 30 older adults with chronic pain who will test all features of the intervention for a period of 8 consecutive weeks. After the trial period, validated instruments will be used to assess usability and acceptability, as well as influence on pain levels and associated physical and psychological symptoms. Participants will be invited to take part in a semistructured telephone interviews after the trial period to explore their experiences using the app. Results: Digitalization of the pain diary and psychotherapeutic content has started. Recruitment of participants for the co-design workshops will start as soon as we have a functioning prototype of the electronic pain diary and EMMA intervention, which is expected to be in September 2021. The feasibility study will start as soon as the co-design process is finished and required changes have been implemented into the pain diary and the EMMA intervention. We expect to start the feasibility study early in 2022. Conclusions: Required changes to assure usability and acceptability will be directly implemented in the app. EMMA brings together a strong body of evidence using cognitive behavioral and self-management theory with contemporary mHealth principles, allowing for a cost-effective intervention that can be used to target chronic pain anywhere and anytime by older adults. Given the ubiquity of mHealth interventions for chronic conditions, the results of this study may serve to inform the development of tailored self-management interventions. International Registered Report Identifier (IRRID): PRR1-10.2196/26930 UR - https://www.researchprotocols.org/2021/8/e26930 UR - http://dx.doi.org/10.2196/26930 UR - http://www.ncbi.nlm.nih.gov/pubmed/34435969 ID - info:doi/10.2196/26930 ER - TY - JOUR AU - Zhang, Lu AU - McLeod, L. Howard AU - Liu, Ke-Ke AU - Liu, Wen-Hui AU - Huang, Hang-Xing AU - Huang, Ya-Min AU - Sun, Shu-Sen AU - Chen, Xiao-Ping AU - Chen, Yao AU - Liu, Fang-Zhou AU - Xiao, Jian PY - 2021/8/16 TI - Effect of Physician-Pharmacist Participation in the Management of Ambulatory Cancer Pain Through a Digital Health Platform: Randomized Controlled Trial JO - JMIR Mhealth Uhealth SP - e24555 VL - 9 IS - 8 KW - cancer pain KW - self-management KW - ambulatory setting KW - digital health KW - physician-pharmacist N2 - Background: Self-management of ambulatory cancer pain is full of challenges. Motivated by the need for better pain management, we developed a WeChat-supported platform, Medication Housekeeper (MediHK), to enhance communication, optimize outcomes, and promote self-management in the home setting. Objective: We conducted a randomized controlled trial to assess whether the joint physician-pharmacist team through MediHK would provide better self-management of ambulatory patients with cancer pain. Methods: Patients were randomly assigned to either an intervention group or control group. During the 4-week study period, the pharmacist would send 24-hour pain diaries daily, adverse drug reaction (ADR) forms every 3 days, and the Brief Pain Inventory form every 15 days to patients in the intervention group via MediHK. If a patient needed a change in drug/dosage or treatment of an ADR after the comprehensive review, the pharmacist would propose pharmacological interventions to the attending physician, who was then responsible for prescribing or adjusting pain medications. If no adjustments were needed, the pharmacist provided appropriate targeted education based on knowledge deficits. Patients in the control group received conventional care and did not receive reminders to fill out the forms. However, if the control group patients filled out a form via MediHK, the pain management team would review and respond in the same way as for the intervention group. The primary outcomes included pain intensity and pain interference in daily life. Secondary outcomes included patient-reported outcome measures, medication adherence, ADRs, and rehospitalization rates. Results: A total of 100 patients were included, with 51 (51%) in the intervention group and 49 (49%) in the control group. The worst pain scores, least pain scores, and average pain scores in the intervention group and the control group were statistically different, with median values of 4 (IQR 3-7) vs 7 (IQR 6-8; P=.001), 1 (IQR 0-2) vs 2 (IQR 1-3; P=.02), and 2 (IQR 2-4) vs 4 (IQR 3-5; P=.001), respectively, at the end of the study. The pain interference on patients' general activity, mood, relationships with others, and interests was reduced, but the difference was not statistically significant compared with the control group (Ps=.10-.76). The medication adherence rate increased from 43% to 63% in the intervention group, compared with an increase of 33% to 51% in the control group (P<.001). The overall number of ADRs increased at 4 weeks, and more ADRs were monitored in the intervention group (P=.003). Rehospitalization rates were similar between the 2 groups. Conclusions: The joint physician-pharmacist team operating through MediHK improved pain management. This study supports the feasibility of integrating the internet into the self-management of cancer pain. Trial Registration: Chinese Clinical Trial Registry ChiCTR1900023075; https://www.chictr.org.cn/showproj.aspx?proj=36901 UR - https://mhealth.jmir.org/2021/8/e24555 UR - http://dx.doi.org/10.2196/24555 UR - http://www.ncbi.nlm.nih.gov/pubmed/34398796 ID - info:doi/10.2196/24555 ER - TY - JOUR AU - Ingvaldsen, Hegna Sigrid AU - Tronvik, Erling AU - Brenner, Eiliv AU - Winnberg, Ingunn AU - Olsen, Alexander AU - Gravdahl, Bruvik Gøril AU - Stubberud, Anker PY - 2021/7/28 TI - A Biofeedback App for Migraine: Development and Usability Study JO - JMIR Form Res SP - e23229 VL - 5 IS - 7 KW - mHealth KW - headache KW - wearables KW - smartphone N2 - Background: Biofeedback is effective in treating migraines. It is believed to have a beneficial effect on autonomous nervous system activity and render individuals resilient to stressors that may trigger a migraine. However, widespread use of biofeedback is hampered by the need for a trained therapist and specialized equipment. Emerging digital health technology, including smartphones and wearables (mHealth), enables new ways of administering biofeedback. Currently, mHealth interventions for migraine appear feasible, but development processes and usability testing remain insufficient. Objective: The objective of this study was to evaluate and improve the feasibility and usability of an mHealth biofeedback treatment app for adults with migraine. Methods: In a prospective development and usability study, 18 adults with migraine completed a 4-week testing period of self-administered therapist-independent biofeedback treatment consisting of a smartphone app connected to wearable sensors (Cerebri, Nordic Brain Tech AS). The app included biofeedback training, instructions for self-delivery, and a headache diary. Two wearable sensors were used to measure surface electromyographic voltage at the trapezius muscle and peripheral skin temperature and heart rate at the right second fingertip. Participants were instructed to complete a daily headache diary entry and biofeedback session of 10 minutes duration. The testing period was preceded by a preusability expectation interview and succeeded by a postusability experience interview. In addition, an evaluation questionnaire was completed at weeks 2 and 4. Adherence was calculated as the proportion of 10-minute sessions completed within the first 28 days of treatment. Usability and feasibility were analyzed and summarized quantitatively and qualitatively. Results: A total of 391 biofeedback sessions were completed with a median of 25 (IQR 17-28) per participant. The mean adherence rate was 0.76 (SD 0.26). The evaluation questionnaire revealed that functionality and design had the highest scores, whereas engagement and biofeedback were lower. Qualitative preexpectation analysis revealed that participants expected to become better familiar with physical signals and gain more understanding of their migraine attacks and noted that the app should be simple and understandable. Postusability analysis indicated that participants had an overall positive user experience with some suggestions for improvement regarding the design of the wearables and app content. The intervention was safe and tolerable. One case of prespecified adverse events was recorded in which a patient developed a skin rash from the sticky surface electromyography electrodes. Conclusions: The app underwent a rigorous development process that indicated an overall positive user experience, good usability, and high adherence rate. This study highlights the value of usability testing in the development of mHealth apps. UR - https://formative.jmir.org/2021/7/e23229 UR - http://dx.doi.org/10.2196/23229 UR - http://www.ncbi.nlm.nih.gov/pubmed/34319243 ID - info:doi/10.2196/23229 ER - TY - JOUR AU - Canares, Therese AU - Parrish, Carisa AU - Santos, Christine AU - Badawi, Alia AU - Stewart, Alyssa AU - Kleinman, Keith AU - Psoter, Kevin AU - McGuire, Joseph PY - 2021/7/28 TI - Pediatric Coping During Venipuncture With Virtual Reality: Pilot Randomized Controlled Trial JO - JMIR Pediatr Parent SP - e26040 VL - 4 IS - 3 KW - pediatrics KW - psychological distress KW - virtual reality KW - procedural pain KW - anxiety KW - phlebotomy N2 - Background: Virtual reality (VR) has shown promise in reducing children?s pain and anxiety during venipuncture, but studies on VR lack objective observations of pediatric coping. Notably, the process of capturing objective behavioral coping data can be labor- and personnel-intensive. Objective: The primary aims of this pilot trial were to assess the feasibility of conducting a trial of VR in a pediatric emergency department and the feasibility of documenting observed coping behaviors during pediatric procedures. Secondarily, this study examined whether VR affects child and caregiver coping and distress during venipuncture in the pediatric emergency department. Methods: This stratified, randomized, controlled pilot trial compared coping and distress between child life?supported VR engagement and child life specialist support without VR during painful procedures in children aged 7-22 years in the pediatric emergency department. An external control (reference group) received no standardized support. Primary feasibility outcomes included rates of recruitment, rates of withdrawal from VR, and rates of completed Child Adult Medical Procedure Interaction Scale-Short Form (CAMPIS-SF) observations. Secondary clinical outcomes were applied to venipuncture procedures and included CAMPIS-SF coping and distress (range 0-1.0), pain and anxiety on a visual analog scale (range 0-10), and cybersickness symptoms. Results: Overall recruitment was 93% (66/71), VR withdrawal rate was 27% (4/15), and of the completed procedures, 100% (63/63) CAMPIS-SF observations were completed. A total of 55 patients undergoing venipuncture in the pediatric emergency department were included in the analyses of clinical outcomes: 15 patients (15 caregivers) randomized to VR, 20 patients (15 caregivers) randomized to child life specialist support, and 20 patients (17 caregivers) in the reference group. Patient coping differed across groups with higher coping in the VR group and child life specialist group than in the reference group (P=.046). There were no significant differences in the distress and pain ratings for patients and caregivers between the groups. Caregivers rated the lowest perceived anxiety in the child life specialist group (P=.03). There was no apparent change in cybersickness symptoms before and after VR use (P=.37). Conclusions: Real-time documentation of observed behaviors in patients and caregivers was feasible during medical procedures in which VR was utilized, particularly with the availability of research staff. VR and child life specialists improved coping in children during venipuncture procedures. Given the high participation rate, future studies to evaluate the efficacy of VR are recommended to determine whether an off-the-shelf VR headset can be a low-cost and low-risk tool to improve children?s coping during venipuncture or other related procedures. Trial Registration: ClinicalTrials.gov NCT03686176; https://clinicaltrials.gov/ct2/show/NCT03686176 UR - https://pediatrics.jmir.org/2021/3/e26040 UR - http://dx.doi.org/10.2196/26040 UR - http://www.ncbi.nlm.nih.gov/pubmed/34319249 ID - info:doi/10.2196/26040 ER - TY - JOUR AU - Fanning, Jason AU - Brooks, K. Amber AU - Hsieh, L. Katherine AU - Kershner, Kyle AU - Furlipa, Joy AU - Nicklas, J. Barbara AU - Rejeski, Jack W. PY - 2021/7/19 TI - Building on Lessons Learned in a Mobile Intervention to Reduce Pain and Improve Health (MORPH): Protocol for the MORPH-II Trial JO - JMIR Res Protoc SP - e29013 VL - 10 IS - 7 KW - aging KW - physical activity KW - sedentary behavior KW - weight loss KW - chronic pain KW - mHealth N2 - Background: Engaging in sufficient levels of physical activity, guarding against sustained sitting, and maintaining a healthy body weight represent important lifestyle strategies for managing older adults? chronic pain. Our first Mobile Health Intervention to Reduce Pain and Improve Health (MORPH) randomized pilot study demonstrated that a partially remote group-mediated diet and daylong activity intervention (ie, a focus on moving often throughout the day) can lead to improved physical function, weight loss, less pain intensity, and fewer minutes of sedentary time. We also identified unique delivery challenges that limited the program?s scalability and potential efficacy. Objective: The purpose of the MORPH-II randomized pilot study is to refine the MORPH intervention package based on feedback from MORPH and evaluate the feasibility, acceptability, and preliminary efficacy of this revised package prior to conducting a larger clinical trial. Methods: The MORPH-II study is an iteration on MORPH designed to pilot a refined framework, enhance scalability through fully remote delivery, and increase uptake of the daylong movement protocol through revised education content and additional personalized remote coaching. Older, obese, and low-active adults with chronic multisite pain (n=30) will be randomly assigned to receive a 12-week remote group-mediated physical activity and dietary weight loss intervention followed by a 12-week maintenance period or a control condition. Those in the intervention condition will partake in weekly social cognitive theory?based group meetings via teleconference software plus one-on-one support calls on a tapered schedule. They will also engage with a tablet application paired with a wearable activity monitor and smart scale designed to provide ongoing social and behavioral support throughout the week. Those in the control group will receive only the self-monitoring tools. Results: Recruitment is ongoing as of January 2021. Conclusions: Findings from MORPH-II will help guide other researchers working to intervene on sedentary behavior through frequent movement in older adults with chronic pain. Trial Registration: ClinicalTrials.gov NCT04655001; https://clinicaltrials.gov/ct2/show/NCT04655001 International Registered Report Identifier (IRRID): PRR1-10.2196/29013 UR - https://www.researchprotocols.org/2021/7/e29013 UR - http://dx.doi.org/10.2196/29013 UR - http://www.ncbi.nlm.nih.gov/pubmed/34279241 ID - info:doi/10.2196/29013 ER - TY - JOUR AU - Olbrecht, A. Vanessa AU - O'Conor, T. Keith AU - Williams, E. Sara AU - Boehmer, O. Chloe AU - Marchant, W. Gilbert AU - Glynn, M. Susan AU - Geisler, J. Kristie AU - Ding, Lili AU - Yang, Gang AU - King, D. Christopher PY - 2021/7/12 TI - Guided Relaxation?Based Virtual Reality for Acute Postoperative Pain and Anxiety in a Pediatric Population: Pilot Observational Study JO - J Med Internet Res SP - e26328 VL - 23 IS - 7 KW - virtual reality KW - guided relaxation?based virtual reality KW - pain KW - anxiety KW - acute pain KW - postoperative pain KW - pediatrics N2 - Background: Distraction-based therapies, such as virtual reality (VR), have been used to reduce pain during acutely painful procedures. However, distraction alone cannot produce prolonged pain reduction to manage sustained postoperative pain. Therefore, the integration of VR with other pain-reducing therapies, like guided relaxation, may enhance its clinical impact. Objective: The goal of this pilot study was to assess the impact of a single guided relaxation?based VR (VR-GR) session on postoperative pain and anxiety reduction in children. We also explored the influence of pain catastrophizing and anxiety sensitivity on this association. Methods: A total of 51 children and adolescents (7-21 years) with postoperative pain and followed by the Acute Pain Service at Cincinnati Children?s Hospital were recruited over an 8-month period to undergo a single VR-GR session. Prior to VR, the patients completed 2 questionnaires: Pain Catastrophizing Scale for Children (PCS-C) and the Child Anxiety Sensitivity Index (CASI). The primary outcome was a change in pain intensity following the VR-GR session (immediately, 15 minutes, and 30 minutes). The secondary outcomes included changes in pain unpleasantness and anxiety. Results: The VR-GR decreased pain intensity immediately (P<.001) and at 30 minutes (P=.04) after the VR session, but not at 15 minutes (P=.16) postsession. Reductions in pain unpleasantness were observed at all time intervals (P<.001 at all intervals). Anxiety was reduced immediately (P=.02) but not at 15 minutes (P=.08) or 30 minutes (P=.30) following VR-GR. Patients with higher CASI scores reported greater reductions in pain intensity (P=.04) and unpleasantness (P=.01) following VR-GR. Pain catastrophizing was not associated with changes in pain and anxiety. Conclusions: A single, short VR-GR session showed transient reductions in pain intensity, pain unpleasantness, and anxiety in children and adolescents with acute postoperative pain. The results call for a future randomized controlled trial to assess the efficacy of VR-GR. Trial Registration: ClinicalTrials.gov NCT04556747; https://clinicaltrials.gov/ct2/show/NCT04556747 UR - https://www.jmir.org/2021/7/e26328 UR - http://dx.doi.org/10.2196/26328 UR - http://www.ncbi.nlm.nih.gov/pubmed/34048358 ID - info:doi/10.2196/26328 ER - TY - JOUR AU - Ridout, Brad AU - Kelson, Joshua AU - Campbell, Andrew AU - Steinbeck, Kate PY - 2021/6/28 TI - Effectiveness of Virtual Reality Interventions for Adolescent Patients in Hospital Settings: Systematic Review JO - J Med Internet Res SP - e24967 VL - 23 IS - 6 KW - virtual reality KW - hospital KW - pain KW - anxiety KW - adolescents N2 - Background: Given the high level of interest and increasing familiarity with virtual reality among adolescents, there is great potential to use virtual reality to address adolescents? unique health care delivery needs while in hospital. While there have been reviews on the use of virtual reality for specific health conditions and procedures, none to date have reviewed the full scope of virtual reality hospital interventions for adolescents who are often combined with children as a homogenous group, despite the fact that adolescents experience virtual environments different from children. Objective: The aim of this review was to systematically identify available evidence regarding the use of virtual reality interventions for adolescent patients in hospital settings to evaluate effectiveness, suitability, and safety and identify opportunities for future research. Methods: PubMed, PsycINFO, Medline, and Scopus databases were searched using keywords and phrases. Retrieved abstracts (n=1525) were double screened, yielding 276 articles for full-text screening. Of these, 8 articles met inclusion criteria. Data were extracted to a standardized coding sheet, and a narrative synthesis was performed due to the heterogeneity of the studies. Results: Four RCTs and 4 single-case reports were identified for inclusion, all of which aimed to reduce pain or anxiety. The scenarios targeted were burn pain, venipuncture, chemotherapy, preoperative anxiety, and palliative care. Three out of 4 RCTs found significant reductions in pain or anxiety outcomes measures when using virtual reality compared to standard care or other distraction techniques; however, only 1 study combined self-reported experiences of pain or anxiety with any physiological measures. Single-case reports relied primarily upon qualitative feedback, with patients reporting reduced pain or anxiety and a preference for virtual reality to no virtual reality. Conclusions: Virtual reality can provide a safe and engaging way to reduce pain and anxiety in adolescents while in hospital, particularly when virtual reality software is highly immersive and specifically designed for therapeutic purposes. As VR becomes more accessible and affordable for use in hospitals, larger and more diverse studies that capitalize on adolescents? interest in and aptitude for virtual reality, and on the full range of capabilities of this emerging technology, are needed to build on these promising results. Trial Registration: PROSPERO International Prospective Register of Systematic Reviews CRD42020198760; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020198760 UR - https://www.jmir.org/2021/6/e24967 UR - http://dx.doi.org/10.2196/24967 UR - http://www.ncbi.nlm.nih.gov/pubmed/34185015 ID - info:doi/10.2196/24967 ER - TY - JOUR AU - Fu, Henry AU - Garrett, Bernie AU - Tao, Gordon AU - Cordingley, Elliott AU - Ofoghi, Zahra AU - Taverner, Tarnia AU - Sun, Crystal AU - Cheung, Teresa PY - 2021/6/24 TI - Virtual Reality?Guided Meditation for Chronic Pain in Patients With Cancer: Exploratory Analysis of Electroencephalograph Activity JO - JMIR Biomed Eng SP - e26332 VL - 6 IS - 2 KW - virtual reality KW - guided meditation KW - neurophysiology KW - electroencephalograph KW - EEG N2 - Background: Mindfulness-based stress reduction has demonstrated some efficacy for chronic pain management. More recently, virtual reality (VR)?guided meditation has been used to assist mindfulness-based stress reduction. Although studies have also found electroencephalograph (EEG) changes in the brain during mindfulness meditation practices, such changes have not been demonstrated during VR-guided meditation. Objective: This exploratory study is designed to explore the potential for recording and analyzing EEG during VR experiences in terms of the power of EEG waveforms, topographic mapping, and coherence. We examine how these measures changed during a VR-guided meditation experience in participants with cancer-related chronic pain. Methods: A total of 10 adult patients with chronic cancer pain underwent a VR-guided meditation experience while EEG signals were recorded during the session using a BioSemi ActiveTwo system (64 channels, standard 10-20 configuration). The EEG recording session consisted of an 8-minute resting condition (pre), a 30-minute sequence of 3 VR-guided meditation conditions (med), and a final rest condition (post). Power spectral density (PSD) was compared between each condition using a cluster-based permutation test and across conditions using multivariate analysis of variance. A topographic analysis, including coherence exploration, was performed. In addition, an exploratory repeated measures correlation was used to examine possible associations between pain scores and EEG signal power. Results: The predominant pattern was for increased ? and ? bandwidth power in the meditation condition (P<.025), compared with both the baseline and postexperience conditions. Increased power in the ? bandwidth was evident, although not statistically significant. The pre versus post comparison also showed changes in the ? and ? bands (P=.02) located around the frontal, central, and parietal cortices. Across conditions, multivariate analysis of variance tests identified 4 clusters with significant (P<.05) PSD differences in the ?, ?, ?, and ? bands located around the frontal, central, and parietal cortices. Topographically, 5 peak channels were identified: AF7, FP2, FC1, CP5, and P5, and verified the changes in power in the different brain regions. Coherence changes were observed primarily between the frontal, parietal, and occipital regions in the ?, ?, and ? bands (P<.0025). No significant associations were observed between pain scores and EEG PSD. Conclusions: This study demonstrates the feasibility of EEG recording in exploring neurophysiological changes in brain activity during VR-guided meditation and its effect on pain reduction. These findings suggest that distinct altered neurophysiological brain signals are detectable during VR-guided meditation. However, these changes were not necessarily associated with pain. These exploratory findings may guide further studies to investigate the highlighted regions and EEG bands with respect to VR-guided meditation. Trial Registration: ClinicalTrials.gov NCT00102401; http://clinicaltrials.gov/ct2/show/NCT00102401 UR - https://biomedeng.jmir.org/2021/2/e26332/ UR - http://dx.doi.org/10.2196/26332 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/26332 ER - TY - JOUR AU - Buck, Christoph AU - Keweloh, Christian AU - Bouras, Adam AU - Simoes, J. Eduardo PY - 2021/6/16 TI - Efficacy of Short Message Service Text Messaging Interventions for Postoperative Pain Management: Systematic Review JO - JMIR Mhealth Uhealth SP - e20199 VL - 9 IS - 6 KW - systematic literature review KW - pain management KW - opioid KW - short message service (SMS) KW - postoperative N2 - Background: Addiction to opiates and synthetic opioids poses a major threat to public health worldwide, with pharmaceutical opioids prescribed to manage pain constituting the main problem. To counteract this threat, suitable pain management strategies should be implemented in health care. Monitoring pain management seems to be feasible using telemedicine with a certain degree of resource intensity and digitization. As a communication channel for this type of monitoring, SMS appears to be a valid alternative. Objective: The aim of this systematic literature review was to (1) provide information on the state of research regarding postoperative pain management via SMS, (2) establish a basic understanding of SMS-based pain management, and (3) provide insight into the feasibility of these management strategies. The research question was as follows: Is postoperative pain management feasible and effective utilizing SMS? Methods: A systematic literature review was performed mainly following the PRISMA guidelines and another guide on performing a systematic literature review for information systems?related research. A search string was developed based on the objectives and research question, and eight databases were searched. Results: The initial search resulted in 2083 records, which could be narrowed down by applying various exclusion criteria. Thereby, 11 articles were identified as relevant, which were accordingly analyzed and evaluated by full-text screening. In all articles, pain management interventions were performed using SMS communication between health care professionals and patients or their legal guardians. A prospective approach was predominantly chosen as the study design (91%) with the leading research objective of determining the intervention?s feasibility (73%). The primary reason for sending SMS messages was to monitor patients (64%). Overall, the use of SMS improved adherence, acceptance, and satisfaction regarding postoperative pain management. With an average response rate of approximately 89.5% (SD 3.8%), the reliability of SMS as a communication and monitoring tool was further emphasized. This response rate is significantly higher than that for email interventions (66.63%, P<.001). Conclusions: This study provides a comprehensive picture of the current status on postoperative pain management by SMS. Communication via SMS was beneficial in all interventions, even preoperative. Six SMS interventions could be certified by the respective institutional review board and three were Health Insurance Portability and Accountability Act?compliant. Therefore, the results of this study could be leveraged to address the opioid epidemic. Overall, the research question could be confirmed. Future research should extend this systematic literature review regarding preoperative pain management. Based on these findings, a pre- and postoperative communication model should be developed to address the opioid epidemic effectively. UR - https://mhealth.jmir.org/2021/6/e20199 UR - http://dx.doi.org/10.2196/20199 UR - http://www.ncbi.nlm.nih.gov/pubmed/34132646 ID - info:doi/10.2196/20199 ER - TY - JOUR AU - Chen, Mingrong AU - Wu, Tingting AU - Lv, Meina AU - Chen, Chunmei AU - Fang, Zongwei AU - Zeng, Zhiwei AU - Qian, Jiafen AU - Jiang, Shaojun AU - Chen, Wenjun AU - Zhang, Jinhua PY - 2021/6/11 TI - Efficacy of Mobile Health in Patients With Low Back Pain: Systematic Review and Meta-analysis of Randomized Controlled Trials JO - JMIR Mhealth Uhealth SP - e26095 VL - 9 IS - 6 KW - mobile health KW - mHealth KW - low back pain KW - meta-analysis KW - pain intensity KW - disability N2 - Background: Low back pain is one of the most common health problems and a main cause of disability, which imposes a great burden on patients. Mobile health (mHealth) affects many aspects of people?s lives, and it has progressed rapidly, showing promise as an effective intervention for patients with low back pain. However, the efficacy of mHealth interventions for patients with low back pain remains unclear; thus, further exploration is necessary. Objective: The purpose of this study was to evaluate the efficacy of mHealth interventions in patients with low back pain compared to usual care. Methods: This was a systematic review and meta-analysis of randomized controlled trials designed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) statement standard. We searched for studies published in English before October 2020 in the PubMed, EMBASE, Web of Science, and Cochrane Library databases. Two researchers independently scanned the literature, extracted data, and assessed the methodological quality of the included studies. Bias risks were assessed using the Cochrane Collaboration tool. We used RevMan 5.4 software to perform the meta-analysis. Results: A total of 9 studies with 792 participants met the inclusion criteria. The simultaneous use of mHealth and usual care showed a better reduction in pain intensity than usual care alone, as measured by the numeric rating scale (mean difference [MD] ?0.85, 95% CI ?1.29 to ?0.40; P<.001), and larger efficacy in reducing disability, as measured by the Rolland-Morris Disability Questionnaire (MD ?1.54, 95% CI ?2.35 to ?0.73; P<.001). Subgroup analyses showed that compared with usual care, mHealth using telephone calls significantly reduced pain intensity (MD ?1.12, 95% CI ?1.71 to ?0.53; P<.001) and disability score (MD ?1.68, 95% CI ?2.74 to ?0.63; P<.001). However, without the use of telephone calls, mHealth had no obvious advantage over usual care in improving pain intensity (MD ?0.48, 95% CI ?1.16 to 0.20; P=.16) and the disability score (MD ?0.41, 95% CI ?1.88 to 1.05; P=.58). The group that received a more sensitive feedback intervention showed a significantly reduced disability score (MD ?4.30, 95% CI ?6.95 to ?1.69; P=.001). Conclusions: The use of simultaneous mHealth and usual care interventions has better efficacy than usual care alone in reducing pain intensity and disability in patients with low back pain. Moreover, the results of subgroup analysis revealed that mHealth using telephone calls might play a positive role in improving pain intensity and disability in patients with low back pain. UR - https://mhealth.jmir.org/2021/6/e26095 UR - http://dx.doi.org/10.2196/26095 UR - http://www.ncbi.nlm.nih.gov/pubmed/34114965 ID - info:doi/10.2196/26095 ER - TY - JOUR AU - Kasaeyan Naeini, Emad AU - Subramanian, Ajan AU - Calderon, Michael-David AU - Zheng, Kai AU - Dutt, Nikil AU - Liljeberg, Pasi AU - Salantera, Sanna AU - Nelson, M. Ariana AU - Rahmani, M. Amir PY - 2021/5/28 TI - Pain Recognition With Electrocardiographic Features in Postoperative Patients: Method Validation Study JO - J Med Internet Res SP - e25079 VL - 23 IS - 5 KW - pain assessment KW - recognition KW - health monitoring KW - wearable electronics KW - machine learning N2 - Background: There is a strong demand for an accurate and objective means of assessing acute pain among hospitalized patients to help clinicians provide pain medications at a proper dosage and in a timely manner. Heart rate variability (HRV) comprises changes in the time intervals between consecutive heartbeats, which can be measured through acquisition and interpretation of electrocardiography (ECG) captured from bedside monitors or wearable devices. As increased sympathetic activity affects the HRV, an index of autonomic regulation of heart rate, ultra?short-term HRV analysis can provide a reliable source of information for acute pain monitoring. In this study, widely used HRV time and frequency domain measurements are used in acute pain assessments among postoperative patients. The existing approaches have only focused on stimulated pain in healthy subjects, whereas, to the best of our knowledge, there is no work in the literature building models using real pain data and on postoperative patients. Objective: The objective of our study was to develop and evaluate an automatic and adaptable pain assessment algorithm based on ECG features for assessing acute pain in postoperative patients likely experiencing mild to moderate pain. Methods: The study used a prospective observational design. The sample consisted of 25 patient participants aged 18 to 65 years. In part 1 of the study, a transcutaneous electrical nerve stimulation unit was employed to obtain baseline discomfort thresholds for the patients. In part 2, a multichannel biosignal acquisition device was used as patients were engaging in non-noxious activities. At all times, pain intensity was measured using patient self-reports based on the Numerical Rating Scale. A weak supervision framework was inherited for rapid training data creation. The collected labels were then transformed from 11 intensity levels to 5 intensity levels. Prediction models were developed using 5 different machine learning methods. Mean prediction accuracy was calculated using leave-one-out cross-validation. We compared the performance of these models with the results from a previously published research study. Results: Five different machine learning algorithms were applied to perform a binary classification of baseline (BL) versus 4 distinct pain levels (PL1 through PL4). The highest validation accuracy using 3 time domain HRV features from a BioVid research paper for baseline versus any other pain level was achieved by support vector machine (SVM) with 62.72% (BL vs PL4) to 84.14% (BL vs PL2). Similar results were achieved for the top 8 features based on the Gini index using the SVM method, with an accuracy ranging from 63.86% (BL vs PL4) to 84.79% (BL vs PL2). Conclusions: We propose a novel pain assessment method for postoperative patients using ECG signal. Weak supervision applied for labeling and feature extraction improves the robustness of the approach. Our results show the viability of using a machine learning algorithm to accurately and objectively assess acute pain among hospitalized patients. International Registered Report Identifier (IRRID): RR2-10.2196/17783 UR - https://www.jmir.org/2021/5/e25079 UR - http://dx.doi.org/10.2196/25079 UR - http://www.ncbi.nlm.nih.gov/pubmed/34047710 ID - info:doi/10.2196/25079 ER - TY - JOUR AU - Roxburgh, Thomas AU - Li, Anthony AU - Guenancia, Charles AU - Pernollet, Patrice AU - Bouleti, Claire AU - Alos, Benjamin AU - Gras, Matthieu AU - Kerforne, Thomas AU - Frasca, Denis AU - Le Gal, François AU - Christiaens, Luc AU - Degand, Bruno AU - Garcia, Rodrigue PY - 2021/5/27 TI - Virtual Reality for Sedation During Atrial Fibrillation Ablation in Clinical Practice: Observational Study JO - J Med Internet Res SP - e26349 VL - 23 IS - 5 KW - connected devices KW - virtual reality KW - atrial fibrillation KW - pain management N2 - Background: Connected devices are dramatically changing many aspects in health care. One such device, the virtual reality (VR) headset, has recently been shown to improve analgesia in a small sample of patients undergoing transcatheter aortic valve implantation. Objective: We aimed to investigate the feasibility and effectiveness of VR in patients undergoing atrial fibrillation (AF) ablation under conscious sedation. Methods: All patients who underwent an AF ablation with VR from March to May 2020 were included. Patients were compared to a consecutive cohort of patients who underwent AF ablation in the 3 months prior to the study. Primary efficacy was assessed by using a visual analog scale, summarizing the overall pain experienced during the ablation. Results: The AF cryoablation procedure with VR was performed for 48 patients (mean age 63.0, SD 10.9 years; n=16, 33.3% females). No patient refused to use the device, although 14.6% (n=7) terminated the VR session prematurely. Preparation of the VR headset took on average 78 (SD 13) seconds. Compared to the control group, the mean perceived pain, assessed with the visual analog scale, was lower in the VR group (3.5 [SD 1.5] vs 4.3 [SD 1.6]; P=.004), and comfort was higher in the VR group (7.5 [SD 1.6] vs 6.8 [SD 1.7]; P=.03). On the other hand, morphine consumption was not different between the groups. Lastly, complications, as well as procedure and fluoroscopy duration, were not different between the two groups. Conclusions: We found that VR was associated with a reduction in the perception of pain in patients undergoing AF ablation under conscious sedation. Our findings demonstrate that VR can be easily incorporated into the standard ablation workflow. UR - https://www.jmir.org/2021/5/e26349 UR - http://dx.doi.org/10.2196/26349 UR - http://www.ncbi.nlm.nih.gov/pubmed/34042589 ID - info:doi/10.2196/26349 ER - TY - JOUR AU - Won, Stevenson Andrea AU - Barreau, C. Ariana AU - Gaertner, Mark AU - Stone, Tristan AU - Zhu, Joshua AU - Wang, Yao Cheng AU - Mackey, Sean PY - 2021/5/26 TI - Assessing the Feasibility of an Open-Source Virtual Reality Mirror Visual Feedback Module for Complex Regional Pain Syndrome: Pilot Usability Study JO - J Med Internet Res SP - e16536 VL - 23 IS - 5 KW - virtual reality KW - pain KW - complex regional pain syndrome KW - CRPS KW - open source KW - mirror visual feedback N2 - Background: Complex regional pain syndrome (CRPS) is a rare and severe chronic pain condition, with effective treatment options not established for many patients. The underlying pathophysiology remains unclear, but there is a growing appreciation for the role of central mechanisms which have formed the basis for brain-based therapies such as transcranial magnetic stimulation and mirror visual feedback (MVF). MVF has been deployed in the treatment of CRPS using both conventional mirrors and virtual reality (VR). Objective: The aim of this study was to further investigate the use of VR in the treatment of patients with unilateral upper limb CRPS. VR has the potential advantage of more flexible and more motivating tasks, as well as the option of tracking patient improvement through the use of movement data. Methods: We describe the development, acceptability, feasibility, and usability of an open-source VR program MVF module designed to be used with consumer VR systems for the treatment of CRPS. The development team was an interdisciplinary group of physical therapists, pain researchers, and VR researchers. Patients recruited from a pain clinic completed 3-5 visits each to trial the system and assessed their experiences in pre- and post-treatment questionnaires. Results: All 9 (100%) participants were able to use the system for 3, 4, or 5 trials each. None of the participants quit any trial due to cybersickness. All 9 (100%) participants reported interest in using the module in the future. Participants? reported average pain scores in the affected limb were not significantly different from baseline during treatment or after treatment (P=.16). We did not find a statistically significant effect on participants? self-reported average pain scores. Conclusions: We propose that this module could be a useful starting point for modification and testing for other researchers. We share modifications to make this module usable with standalone headsets and finger tracking. Next steps include adapting this module for at-home use, or for use with participants with lower limb pain. UR - https://www.jmir.org/2021/5/e16536 UR - http://dx.doi.org/10.2196/16536 UR - http://www.ncbi.nlm.nih.gov/pubmed/34037530 ID - info:doi/10.2196/16536 ER - TY - JOUR AU - Magee, Reece Michael AU - McNeilage, Gray Amy AU - Avery, Nicholas AU - Glare, Paul AU - Ashton-James, Elizabeth Claire PY - 2021/5/18 TI - mHealth Interventions to Support Prescription Opioid Tapering in Patients With Chronic Pain: Qualitative Study of Patients? Perspectives JO - JMIR Form Res SP - e25969 VL - 5 IS - 5 KW - prescription opioids KW - chronic noncancer pain KW - tapering KW - digital health KW - support KW - mobile health technology KW - SMS KW - mobile phone N2 - Background: Patients with chronic pain who are tapering prescription opioids report a need for greater support for coping with symptoms of pain and withdrawal. Mobile health (mHealth) technologies (SMS text messaging? or app-based) have the potential to provide patients with educational, emotional, and motivational support for opioid tapering beyond what is offered by their health care provider. However, it is not known whether patients with chronic pain who are tapering opioids would be willing or able to engage with technology-based support. Objective: This study aims to examine patients? use of mobile technologies in health care, interest in using mHealth support, preferences for the form and content of mHealth support, and potential barriers to and facilitators of engagement with mHealth support for opioid tapering. Methods: A total of 21 patients (11 women and 10 men; age range 29-83 years) with chronic noncancer pain on long-term opioid therapy who had recently initiated a voluntary opioid taper were recruited from primary and tertiary care clinics in metropolitan and regional Australia for a larger study of patients? experiences of opioid tapering. Participants had been taking prescription opioids for a mean duration of 13 (SD 9.6; range 0.25-30) years at the time of the study. Survey items characterized participants? typical mobile phone use and level of interest in mobile technology?based support for opioid tapering. Semistructured interviews further explored patients? use of mobile technologies and their interest in, preferences for, and perspectives on potential barriers to and facilitators of engagement with mHealth support for opioid tapering. Two researchers collaborated to conduct a thematic analysis of the interview data. Results: All participants reported owning and using a mobile phone, and most (17/21, 81%) participants reported using mobile apps. The majority of participants expressed interest in SMS text messaging?based (17/21, 81%) and app-based (15/21, 71%) support for opioid tapering. Participants expected that messages delivering both informational and socioemotional support would be helpful. Participants expected that access to technology, mobile reception, internet connectivity, vision impairment, and low self-efficacy for using apps may be barriers to user engagement. Patients expected that continuity of care from their health care provider, flexible message dosing, responsivity, and familiarity with pain self-management strategies would increase user engagement. Conclusions: The results of this study indicate that patients with chronic noncancer pain may be willing to engage with SMS text messaging?based and app-based mHealth interventions to support opioid tapering. However, the feasibility and acceptability of these interventions may depend on how patients? preferences for functionality, content, and design are addressed. UR - https://formative.jmir.org/2021/5/e25969 UR - http://dx.doi.org/10.2196/25969 UR - http://www.ncbi.nlm.nih.gov/pubmed/34003133 ID - info:doi/10.2196/25969 ER - TY - JOUR AU - Lopes, Filipa AU - Rodrigues, Mário AU - Silva, G. Anabela PY - 2021/5/14 TI - User-Centered Development of a Mobile App for Biopsychosocial Pain Assessment in Adults: Usability, Reliability, and Validity Study JO - JMIR Mhealth Uhealth SP - e25316 VL - 9 IS - 5 KW - pain assessment KW - mobile app KW - validity KW - reliability KW - usability KW - mHealth KW - pain KW - user-centered design N2 - Background: Pain-related mobile apps targeting pain assessment commonly limit pain assessment to pain behaviors and physiological aspects. However, current guidelines state that pain assessment should follow the biopsychosocial model, clearly addressing biological, psychological, and social aspects of the pain experience. Existing reviews also highlight that pain specialists and end users are not commonly involved in the development process of mobile apps for pain assessment, negatively affecting the quality of the available apps. Objective: This study aimed to develop a mobile app for pain assessment (AvaliaDor) and assess its usability, validity, reliability, and measurement error in a sample of real patients with chronic pain recruited from a physiotherapy clinic. Methods: This study was divided into 2 phases: phase 1?development of the AvaliaDor app; and phase 2?assessment of the apps? usability, reliability, measurement error, and validity. AvaliaDor was developed (phase 1) based on the literature and the recommendations of physiotherapists and patients with pain in cycles of evaluation, inclusion of recommendations, and reevaluation until no further changes were required. The final version of the app was then tested in patients with musculoskeletal pain attending a private physiotherapy practice (phase 2) who were asked to use the app twice on 2 consecutive days for reliability purposes. In addition, participants had to complete a set of paper-based scales (Brief Pain Inventory, painDETECT, Pain Catastrophizing Scale, and Tampa Scale for Kinesiophobia), which were used to assess the validity (criterion validity and hypothesis testing) of the app, and the Post-Study System Usability Questionnaire was used to assess its usability. Results: The development process (phase 1) included 5 physiotherapists external to the research team and 5 patients with musculoskeletal pain, and it resulted in the creation of an app named AvaliaDor, which includes an assessment of pain intensity, location, and phenotype; associated disability; and the issues of pain catastrophizing and fear of movement. A total of 52 patients with pain (mean age 50.12 years, SD 11.71 years; 39 females) participated in phase 2 and used the app twice. The Pearson correlation coefficient between the scores on the paper-based scales and the app ranged between 0.81 and 0.93 for criterion validity and between 0.41 and 0.59 for hypothesis testing. Test-retest reliability was moderate to good (intraclass correlation coefficient between 0.67 and 0.90) and the score for usability was 1.16 (SD 0.27), indicating good usability. Conclusions: A mobile app named AvaliaDor was developed to assess the intensity, location, and phenotype of pain; associated disability; and the issues of pain catastrophizing and fear of movement in a user-centered design process. The app was shown to be usable, valid, and reliable for assessing pain from a biopsychosocial perspective in a heterogeneous group of patients with pain. Future work can explore the long-term use of AvaliaDor in clinical contexts and its advantages for the assessment and management of patients with pain. UR - https://mhealth.jmir.org/2021/5/e25316 UR - http://dx.doi.org/10.2196/25316 UR - http://www.ncbi.nlm.nih.gov/pubmed/33988515 ID - info:doi/10.2196/25316 ER - TY - JOUR AU - Badawy, M. Sherif AU - Abebe, Z. Kaleab AU - Reichman, A. Charlotte AU - Checo, Grace AU - Hamm, E. Megan AU - Stinson, Jennifer AU - Lalloo, Chitra AU - Carroll, Patrick AU - Saraf, L. Santosh AU - Gordeuk, R. Victor AU - Desai, Payal AU - Shah, Nirmish AU - Liles, Darla AU - Trimnell, Cassandra AU - Jonassaint, R. Charles PY - 2021/5/14 TI - Comparing the Effectiveness of Education Versus Digital Cognitive Behavioral Therapy for Adults With Sickle Cell Disease: Protocol for the Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications (CaRISMA) Study JO - JMIR Res Protoc SP - e29014 VL - 10 IS - 5 KW - sickle cell anemia KW - sickle cell disease KW - pain KW - depression KW - depressive symptoms KW - quality of life KW - digital KW - mHealth KW - eHealth KW - CBT KW - cognitive behavioral therapy KW - education KW - mobile phone N2 - Background: Patients with sickle cell disease (SCD) experience significant medical and psychological stressors that affect their mental health, well-being, and disease outcomes. Digital cognitive behavioral therapy (CBT) has been used in other patient populations and has demonstrated clinical benefits. Although evidence-based, nonpharmacological interventions for pain management are widely used in other populations, these treatments have not been well studied in SCD. Currently, there are no adequately powered large-scale clinical trials to evaluate the effectiveness and dissemination potential of behavioral pain management for adults with SCD. Furthermore, some important details regarding behavioral therapies in SCD remain unclear?in particular, what works best for whom and when. Objective: Our primary goal is to compare the effectiveness of two smartphone?delivered programs for reducing SCD pain symptoms: digital CBT versus pain and SCD education (Education). Our secondary goal is to assess whether baseline depression symptoms moderate the effect of interventions on pain outcomes. We hypothesize that digital CBT will confer greater benefits on pain outcomes and depressive symptoms at 6 months and a greater reduction in health care use (eg, opioid prescriptions or refills or acute care visits) over 12 months. Methods: The CaRISMA (Cognitive Behavioral Therapy and Real-time Pain Management Intervention for Sickle Cell via Mobile Applications) study is a multisite comparative effectiveness trial funded by the Patient-Centered Outcomes Research Institute. CaRISMA is conducted at six clinical academic sites, in partnership with four community-based organizations. CaRISMA will evaluate the effectiveness of two 12-week health coach?supported digital health programs with a total of 350 participants in two groups: CBT (n=175) and Education (n=175). Participants will complete a series of questionnaires at baseline and at 3, 6, and 12 months. The primary outcome will be the change in pain interference between the study arms. We will also evaluate changes in pain intensity, depressive symptoms, other patient-reported outcomes, and health care use as secondary outcomes. We have 80% power to detect a difference of 0.37 SDs between study arms on 6-month changes in the outcomes with 15% expected attrition at 6 months. An exploratory analysis will examine whether baseline depression symptoms moderate the effect of the intervention on pain interference. Results: This study will be conducted from March 2021 through February 2022, with results expected to be available in February 2023. Conclusions: Patients with SCD experience significant disease burden, psychosocial stress, and impairment of their quality of life. CaRISMA proposes to leverage digital technology and overcome barriers to the routine use of behavioral treatments for pain and depressive symptoms in the treatment of adults with SCD. The study will provide data on the comparative effectiveness of digital CBT and Education approaches and evaluate the potential for implementing evidence-based behavioral interventions to manage SCD pain. Trial Registration: ClinicalTrials.gov NCT04419168; https://clinicaltrials.gov/ct2/show/NCT04419168. International Registered Report Identifier (IRRID): PRR1-10.2196/29014 UR - https://www.researchprotocols.org/2021/5/e29014 UR - http://dx.doi.org/10.2196/29014 UR - http://www.ncbi.nlm.nih.gov/pubmed/33988517 ID - info:doi/10.2196/29014 ER - TY - JOUR AU - Tran, E. Johanna AU - Fowler, A. Christopher AU - Delikat, Jemy AU - Kaplan, Howard AU - Merzier, M. Marie AU - Schlesinger, R. Michelle AU - Litzenberger, Stefan AU - Marszalek, M. Jacob AU - Scott, Steven AU - Winkler, L. Sandra PY - 2021/5/10 TI - Immersive Virtual Reality to Improve Outcomes in Veterans With Stroke: Protocol for a Single-Arm Pilot Study JO - JMIR Res Protoc SP - e26133 VL - 10 IS - 5 KW - stroke KW - immersive virtual reality KW - feasibility KW - veterans affairs KW - veterans KW - pilot KW - recovery KW - upper extremity N2 - Background: Over the last decade, virtual reality (VR) has emerged as a cutting-edge technology in stroke rehabilitation. VR is defined as a type of computer-user interface that implements real-time simulation of an activity or environment allowing user interaction via multiple sensory modalities. In a stroke population, VR interventions have been shown to enhance motor, cognitive, and psychological recovery when utilized as a rehabilitation adjunct. VR has also demonstrated noninferiority to usual care therapies for stroke rehabilitation. Objective: The proposed pilot study aims to (1) determine the feasibility and tolerability of using a therapeutic VR platform in an inpatient comprehensive stroke rehabilitation program and (2) estimate the initial clinical efficacy (effect size) associated with the VR platform using apps for pain distraction and upper extremity exercise for poststroke neurologic recovery. Methods: This study will be conducted in the Comprehensive Integrated Inpatient Rehabilitation Program at the James A Haley Veterans? Hospital. Qualitative interviews will be conducted with 10 clinical staff members to assess the feasibility of the VR platform from the clinician perspective. A prospective within-subject pretest-posttest pilot design will be used to examine the tolerability of the VR platform and the clinical outcomes (ie, upper extremity neurologic recovery, hand dexterity, pain severity) in 10 veteran inpatients. A VR platform consisting of commercially available pain distraction and upper extremity apps will be available at the participants? bedside for daily use during their inpatient stay (approximately 4-6 weeks). Clinician interviews will be analyzed using qualitative descriptive analysis. Cohen d effect sizes with corresponding 95% CIs will be calculated for upper extremity neurologic recovery, hand dexterity, and pain. The proportion of participants who achieve minimal clinically important difference after using the VR platform will be calculated for each clinical outcome. Results: This study was selected for funding in August 2020. Institutional review board approval was received in October 2020. The project start date was December 2020. The United States Department has issued a moratorium on in-person research activities secondary to COVID-19. Data collection will commence once this moratorium is lifted. Conclusions: Our next step is to conduct a large multi-site clinical trial that will incorporate the lessons learned from this pilot feasibility study to test the efficacy of a VR intervention in inpatient rehabilitation and transition to home environments. When VR is used in patients? rooms, it serves to provide additional therapy and may reduce clinician burden. VR also presents an opportunity similar to home-based practice exercises. VR can be implemented in both clinical settings and people?s own homes, where engagement in ongoing self-management approaches is often most challenging. This unique experience offers the potential for seamless transition from inpatient rehabilitation to the home. International Registered Report Identifier (IRRID): PRR1-10.2196/26133 UR - https://www.researchprotocols.org/2021/5/e26133 UR - http://dx.doi.org/10.2196/26133 UR - http://www.ncbi.nlm.nih.gov/pubmed/33970110 ID - info:doi/10.2196/26133 ER - TY - JOUR AU - Aqajari, Hossein Seyed Amir AU - Cao, Rui AU - Kasaeyan Naeini, Emad AU - Calderon, Michael-David AU - Zheng, Kai AU - Dutt, Nikil AU - Liljeberg, Pasi AU - Salanterä, Sanna AU - Nelson, M. Ariana AU - Rahmani, M. Amir PY - 2021/5/5 TI - Pain Assessment Tool With Electrodermal Activity for Postoperative Patients: Method Validation Study JO - JMIR Mhealth Uhealth SP - e25258 VL - 9 IS - 5 KW - pain assessment KW - recognition KW - health monitoring KW - wearable electronics KW - machine learning KW - electrodermal activity KW - post-op patients N2 - Background: Accurate, objective pain assessment is required in the health care domain and clinical settings for appropriate pain management. Automated, objective pain detection from physiological data in patients provides valuable information to hospital staff and caregivers to better manage pain, particularly for patients who are unable to self-report. Galvanic skin response (GSR) is one of the physiologic signals that refers to the changes in sweat gland activity, which can identify features of emotional states and anxiety induced by varying pain levels. This study used different statistical features extracted from GSR data collected from postoperative patients to detect their pain intensity. To the best of our knowledge, this is the first work building pain models using postoperative adult patients instead of healthy subjects. Objective: The goal of this study was to present an automatic pain assessment tool using GSR signals to predict different pain intensities in noncommunicative, postoperative patients. Methods: The study was designed to collect biomedical data from postoperative patients reporting moderate to high pain levels. We recruited 25 participants aged 23-89 years. First, a transcutaneous electrical nerve stimulation (TENS) unit was employed to obtain patients' baseline data. In the second part, the Empatica E4 wristband was worn by patients while they were performing low-intensity activities. Patient self-report based on the numeric rating scale (NRS) was used to record pain intensities that were correlated with objectively measured data. The labels were down-sampled from 11 pain levels to 5 different pain intensities, including the baseline. We used 2 different machine learning algorithms to construct the models. The mean decrease impurity method was used to find the top important features for pain prediction and improve the accuracy. We compared our results with a previously published research study to estimate the true performance of our models. Results: Four different binary classification models were constructed using each machine learning algorithm to classify the baseline and other pain intensities (Baseline [BL] vs Pain Level [PL] 1, BL vs PL2, BL vs PL3, and BL vs PL4). Our models achieved higher accuracy for the first 3 pain models than the BioVid paper approach despite the challenges in analyzing real patient data. For BL vs PL1, BL vs PL2, and BL vs PL4, the highest prediction accuracies were achieved when using a random forest classifier (86.0, 70.0, and 61.5, respectively). For BL vs PL3, we achieved an accuracy of 72.1 using a k-nearest-neighbor classifier. Conclusions: We are the first to propose and validate a pain assessment tool to predict different pain levels in real postoperative adult patients using GSR signals. We also exploited feature selection algorithms to find the top important features related to different pain intensities. International Registered Report Identifier (IRRID): RR2-10.2196/17783 UR - https://mhealth.jmir.org/2021/5/e25258 UR - http://dx.doi.org/10.2196/25258 UR - http://www.ncbi.nlm.nih.gov/pubmed/33949957 ID - info:doi/10.2196/25258 ER - TY - JOUR AU - Vranceanu, Ana-Maria AU - Bakhshaie, Jafar AU - Reichman, Mira AU - Doorley, James AU - Elwy, Rani A. AU - Jacobs, Cale AU - Chen, Neal AU - Esposito, John AU - Laverty, David AU - Matuszewski, E. Paul AU - Fatehi, Amirreza AU - Bowers, C. Lucy AU - Harris, Mitchel AU - Ring, David PY - 2021/4/28 TI - A Live Video Program to Prevent Chronic Pain and Disability in At-Risk Adults With Acute Orthopedic Injuries (Toolkit for Optimal Recovery): Protocol for a Multisite Feasibility Study JO - JMIR Res Protoc SP - e28155 VL - 10 IS - 4 KW - orthopedic KW - musculoskeletal KW - prevention KW - chronic pain KW - disability KW - intervention KW - video KW - telehealth KW - mobile phone N2 - Background: Despite the pivotal role of psychosocial factors in pain and disability after orthopedic injury, there are no evidence-based preventive interventions targeting psychosocial factors in patients with acute orthopedic injuries. We developed the first mind-body intervention focused on optimizing recovery and improving pain and disability in patients with acute orthopedic injuries who exhibit high levels of catastrophic thinking about pain and/or pain anxiety (Toolkit for Optimal Recovery [TOR] after orthopedic injury). In a pilot single-site randomized controlled trial (RCT), the TOR met a priori set benchmarks for feasibility, acceptability, and satisfaction. The next step in developing TOR is to conduct a multisite feasibility RCT to set the stage for a scientifically rigorous hybrid efficacy-effectiveness trial. Objective: The objective of this study is to conduct a rigorous multisite feasibility RCT of TOR to determine whether the intervention and study methodology meet a priori set benchmarks necessary for the successful implementation of a future multisite hybrid efficacy-effectiveness trial. In this paper, we describe the study design, manualized treatments, and specific strategies used to conduct this multisite feasibility RCT investigation. Methods: This study will be conducted at 3 geographically diverse level 1 trauma centers, anonymized as sites A, B, and C. We will conduct a multisite feasibility RCT of TOR versus the minimally enhanced usual care (MEUC) control (60 patients per site; 30 per arm) targeting a priori set feasibility benchmarks. Adult patients with acute orthopedic injuries who endorse high pain catastrophizing or pain anxiety will be recruited approximately 1-2 months after injury or surgery (baseline). Participants randomized to the TOR will receive a 4-session mind-body treatment delivered via a secure live video by trained clinical psychologists. Participants randomized to the MEUC will receive an educational booklet. Primary outcomes include feasibility of recruitment, appropriateness, feasibility of data collection, acceptability of TOR (adherence to sessions), and treatment satisfaction across all sites. We will also collect data on secondary implementation outcomes, as well as pain severity, physical and emotional function, coping skills, and adverse events. Outcomes will be assessed at baseline, posttreatment, and at the 3-month follow-up. Results: Enrollment for the RCT is estimated to begin in June 2021. The target date of completion of the feasibility RCT is April 2024. The institutional review board approval has been obtained (January 2020). Conclusions: This investigation examines the multisite feasibility of TOR administered via live videoconferencing in adult patients with acute orthopedic injuries. If feasible, the next step is a multisite, hybrid efficacy-effectiveness trial of TOR versus MEUC. Preventive psychosocial interventions can provide a new way to improve patient and provider satisfaction and decrease suffering and health care costs among patients with orthopedic injuries who are at risk for chronic pain and disability. International Registered Report Identifier (IRRID): PRR1-10.2196/28155 UR - https://www.researchprotocols.org/2021/4/e28155 UR - http://dx.doi.org/10.2196/28155 UR - http://www.ncbi.nlm.nih.gov/pubmed/33908886 ID - info:doi/10.2196/28155 ER - TY - JOUR AU - Logan, E. Deirdre AU - Simons, E. Laura AU - Caruso, J. Thomas AU - Gold, I. Jeffrey AU - Greenleaf, Walter AU - Griffin, Anya AU - King, D. Christopher AU - Menendez, Maria AU - Olbrecht, A. Vanessa AU - Rodriguez, Samuel AU - Silvia, Megan AU - Stinson, N. Jennifer AU - Wang, Ellen AU - Williams, E. Sara AU - Wilson, Luke PY - 2021/4/26 TI - Leveraging Virtual Reality and Augmented Reality to Combat Chronic Pain in Youth: Position Paper From the Interdisciplinary Network on Virtual and Augmented Technologies for Pain Management JO - J Med Internet Res SP - e25916 VL - 23 IS - 4 KW - virtual reality KW - pediatric KW - chronic pain N2 - Background: Virtual reality (VR) and augmented reality (AR) interventions are emerging as promising tools in the treatment of pediatric chronic pain conditions. However, in this young field, there is little consensus to guide the process of engaging in the development and evaluation of targeted VR-based interventions. Objective: The INOVATE-Pain (Interdisciplinary Network on Virtual and Augmented Technologies for Pain management) consortium aims to advance the field of VR for pediatric chronic pain rehabilitation by providing guidance for best practices in the design, evaluation, and dissemination of VR-based interventions targeting this population. Methods: An interdisciplinary meeting of 16 academics, clinicians, industry partners, and philanthropy partners was held in January 2020. Results: Reviewing the state of the field, the consortium identified important directions for research-driven innovation in VR and AR clinical care, highlighted key opportunities and challenges facing the field, and established a consensus on best methodological practices to adopt in future efforts to advance the research and practice of VR and AR in pediatric pain. The consortium also identified important next steps to undertake to continue to advance the work in this promising new area of digital health pain interventions. Conclusions: To realize the promise of this realm of innovation, key ingredients for success include productive partnerships among industry, academic, and clinical stakeholders; a uniform set of outcome domains and measures for standardized evaluation; and widespread access to the latest opportunities, tools, and resources. The INOVATE-Pain collaborative hopes to promote the creation, rigorous yet efficient evaluation, and dissemination of innovative VR-based interventions to reduce pain and improve quality of life for children. UR - https://www.jmir.org/2021/4/e25916 UR - http://dx.doi.org/10.2196/25916 UR - http://www.ncbi.nlm.nih.gov/pubmed/33667177 ID - info:doi/10.2196/25916 ER - TY - JOUR AU - Szilagyi, Istvan-Szilard AU - Ullrich, Torsten AU - Lang-Illievich, Kordula AU - Klivinyi, Christoph AU - Schittek, Alexander Gregor AU - Simonis, Holger AU - Bornemann-Cimenti, Helmar PY - 2021/4/22 TI - Google Trends for Pain Search Terms in the World?s Most Populated Regions Before and After the First Recorded COVID-19 Case: Infodemiological Study JO - J Med Internet Res SP - e27214 VL - 23 IS - 4 KW - COVID-19 KW - data mining KW - Google Trends KW - incidence KW - internet KW - interest KW - pain KW - research KW - trend N2 - Background: Web-based analysis of search queries has become a very useful method in various academic fields for understanding timely and regional differences in the public interest in certain terms and concepts. Particularly in health and medical research, Google Trends has been increasingly used over the last decade. Objective: This study aimed to assess the search activity of pain-related parameters on Google Trends from among the most populated regions worldwide over a 3-year period from before the report of the first confirmed COVID-19 cases in these regions (January 2018) until December 2020. Methods: Search terms from the following regions were used for the analysis: India, China, Europe, the United States, Brazil, Pakistan, and Indonesia. In total, 24 expressions of pain location were assessed. Search terms were extracted using the local language of the respective country. Python scripts were used for data mining. All statistical calculations were performed through exploratory data analysis and nonparametric Mann?Whitney U tests. Results: Although the overall search activity for pain-related terms increased, apart from pain entities such as headache, chest pain, and sore throat, we observed discordant search activity. Among the most populous regions, pain-related search parameters for shoulder, abdominal, and chest pain, headache, and toothache differed significantly before and after the first officially confirmed COVID-19 cases (for all, P<.001). In addition, we observed a heterogenous, marked increase or reduction in pain-related search parameters among the most populated regions. Conclusions: As internet searches are a surrogate for public interest, we assume that our data are indicative of an increased incidence of pain after the onset of the COVID-19 pandemic. However, as these increased incidences vary across geographical and anatomical locations, our findings could potentially facilitate the development of specific strategies to support the most affected groups. UR - https://www.jmir.org/2021/4/e27214 UR - http://dx.doi.org/10.2196/27214 UR - http://www.ncbi.nlm.nih.gov/pubmed/33844638 ID - info:doi/10.2196/27214 ER - TY - JOUR AU - White, M. Katie AU - Ivan, Alina AU - Williams, Ruth AU - Galloway, B. James AU - Norton, Sam AU - Matcham, Faith PY - 2021/3/9 TI - Remote Measurement in Rheumatoid Arthritis: Qualitative Analysis of Patient Perspectives JO - JMIR Form Res SP - e22473 VL - 5 IS - 3 KW - rheumatoid arthritis KW - remote measurement technologies KW - symptom assessment KW - disease management KW - smartphone KW - qualitative research KW - mobile phone N2 - Background: Rheumatoid arthritis (RA) is characterized by recurrent fluctuations in symptoms such as joint pain, swelling, and stiffness. Remote measurement technologies (RMTs) offer the opportunity to track symptoms continuously and in real time; therefore, they may provide a more accurate picture of RA disease activity as a complement to prescheduled general practitioner appointments. Previous research has shown patient interest in remote symptom tracking in RA and has provided evidence for its clinical validity. However, there is a lack of co-design in the current development of systems, and the features of RMTs that best promote optimal engagement remain unclear. Objective: This study represents the first in a series of work that aims to develop a multiparametric RMT system for symptom tracking in RA. The objective of this study is to determine the important outcomes for disease management in patients with RA and how these can be best captured via remote measurement. Methods: A total of 9 patients (aged 23-77 years; mean 55.78, SD 17.54) with RA were recruited from King?s College Hospital to participate in two semistructured focus groups. Both focus group discussions were conducted by a facilitator and a lived-experience researcher. The sessions were recorded, transcribed, independently coded, and analyzed for themes. Results: Thematic analysis identified a total of four overarching themes: important symptoms and outcomes in RA, management of RA symptoms, views on the current health care system, and views on the use of RMTs in RA. Mobility and pain were key symptoms to consider for symptom tracking as well as symptom triggers. There is a general consensus that the ability to track fluctuations and transmit such data to clinicians would aid in individual symptom management and the effectiveness of clinical care. Suggestions for visually capturing symptom fluctuations in an app were proposed. Conclusions: The findings support previous work on the acceptability of RMT with RA disease management and address key outcomes for integration into a remote monitoring system for RA self-management and clinical care. Clear recommendations for RMT design are proposed. Future work will aim to take these recommendations into a user testing phase. UR - https://formative.jmir.org/2021/3/e22473 UR - http://dx.doi.org/10.2196/22473 UR - http://www.ncbi.nlm.nih.gov/pubmed/33687333 ID - info:doi/10.2196/22473 ER - TY - JOUR AU - Bhatia, Anuj AU - Kara, Jamal AU - Janmohamed, Tahir AU - Prabhu, Atul AU - Lebovic, Gerald AU - Katz, Joel AU - Clarke, Hance PY - 2021/3/4 TI - User Engagement and Clinical Impact of the Manage My Pain App in Patients With Chronic Pain: A Real-World, Multi-site Trial JO - JMIR Mhealth Uhealth SP - e26528 VL - 9 IS - 3 KW - pain KW - psychology KW - patient-oriented research KW - quality of life KW - digital health KW - chronic pain KW - pain app KW - virtual care KW - mHealth KW - pain management KW - chronic disease management KW - remote monitoring KW - app KW - engagement KW - impact KW - outcome N2 - Background: Chronic pain imposes a large burden on individuals and society. A patient-centric digital chronic pain management app called Manage My Pain (MMP) can be used to enhance communication between providers and patients and promote self-management. Objective: The purpose of this study was to evaluate the real-world engagement of patients in urban and rural settings in Ontario, Canada with the MMP app alongside their standard of care and assess the impact of its usage on clinical outcomes of pain and related mental health. Methods: A total of 246 participants with chronic pain at a rural and 2 urban pain clinics were recruited into this prospective, open-label, exploratory study that compared the use of MMP, a digital health app for pain that incorporates validated questionnaires and provides patients with summarized reports of their progress in combination with standard care (app group), against data entered on paper-based questionnaires (nonapp group). Participants completed validated questionnaires on anxiety, depression, pain catastrophizing, satisfaction, and daily opioid consumption up to 4.5 months after the initial visit (short-term follow-up) and between 4.5 and 7 months after the initial visit (long-term follow-up). Engagement and clinical outcomes were compared between participants in the two groups. Results: A total of 73.6% (181/246) of the participants agreed to use the app, with 63.4% (111/175) of them using it for at least one month. Individuals who used the app rated lower anxiety (reduction in Generalized Anxiety Disorder 7-item questionnaire score by 2.10 points, 95% CI ?3.96 to ?0.24) at short-term follow-up and had a greater reduction in pain catastrophizing (reduction in Pain Catastrophizing Scale score by 5.23 points, 95% CI ?9.55 to ?0.91) at long-term follow-up relative to patients with pain who did not engage with the MMP app. Conclusions: The use of MMP by patients with chronic pain is associated with engagement and improvements in self-reported anxiety and pain catastrophizing. Further research is required to understand factors that impact continued engagement and clinical outcomes in patients with chronic pain. Trial Registration: ClinicalTrials.gov NCT04762329; https://clinicaltrials.gov/ct2/show/NCT04762329 UR - https://mhealth.jmir.org/2021/3/e26528 UR - http://dx.doi.org/10.2196/26528 UR - http://www.ncbi.nlm.nih.gov/pubmed/33661130 ID - info:doi/10.2196/26528 ER - TY - JOUR AU - Garcia, M. Laura AU - Birckhead, J. Brandon AU - Krishnamurthy, Parthasarathy AU - Sackman, Josh AU - Mackey, G. Ian AU - Louis, G. Robert AU - Salmasi, Vafi AU - Maddox, Todd AU - Darnall, D. Beth PY - 2021/2/22 TI - An 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality Program for Chronic Low Back Pain: Double-Blind, Randomized, Placebo-Controlled Trial Conducted During COVID-19 JO - J Med Internet Res SP - e26292 VL - 23 IS - 2 KW - virtual reality KW - low back pain KW - opioids KW - chronic pain KW - behavioral health KW - pain treatment, randomized controlled trial KW - COVID-19 N2 - Background: Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. Objective: We aimed to conduct a double-blind, parallel-arm, single-cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. Methods: A national online convenience sample of individuals with self-reported nonmalignant low back pain with duration of 6 months or more and with average pain intensity of 4 or more/10 was enrolled and randomized 1:1 to 1 of 2 daily (56-day) VR programs: (1) EaseVRx (immersive pain relief skills VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were the between-group effect of EaseVRx versus Sham VR across time points, and the between?within interaction effect representing the change in average pain intensity and pain-related interference with activity, stress, mood, and sleep over time (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. Results: The study sample was 179 adults (female: 76.5%, 137/179; Caucasian: 90.5%, 162/179; at least some college education: 91.1%, 163/179; mean age: 51.5 years [SD 13.1]; average pain intensity: 5/10 [SD 1.2]; back pain duration ?5 years: 67%, 120/179). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx versus Sham VR (P<.001). For the between-groups factor, EaseVRx was superior to Sham VR for all primary outcomes (highest P value=.009), and between-groups Cohen d effect sizes ranged from 0.40 to 0.49, indicating superiority was moderately clinically meaningful. For EaseVRx, large pre?post effect sizes ranged from 1.17 to 1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. Between-group comparisons for Physical Function and Sleep Disturbance showed superiority for the EaseVRx group versus the Sham VR group (P=.022 and .013, respectively). Pain catastrophizing, pain self-efficacy, pain acceptance, prescription opioid use (morphine milligram equivalent) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (P<.01) but not for Sham VR. Conclusions: EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand nonpharmacologic treatment for chronic low back pain. Trial Registration: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 International Registered Report Identifier (IRRID): RR2-10.2196/25291 UR - https://www.jmir.org/2021/2/e26292 UR - http://dx.doi.org/10.2196/26292 UR - http://www.ncbi.nlm.nih.gov/pubmed/33484240 ID - info:doi/10.2196/26292 ER - TY - JOUR AU - Choi, Byung-Moon AU - Yim, Yeon Ji AU - Shin, Hangsik AU - Noh, Gyujeong PY - 2021/2/3 TI - Novel Analgesic Index for Postoperative Pain Assessment Based on a Photoplethysmographic Spectrogram and Convolutional Neural Network: Observational Study JO - J Med Internet Res SP - e23920 VL - 23 IS - 2 KW - analgesic index KW - machine learning KW - pain assessment KW - photoplethysmogram KW - postoperative pain KW - spectrogram N2 - Background: Although commercially available analgesic indices based on biosignal processing have been used to quantify nociception during general anesthesia, their performance is low in conscious patients. Therefore, there is a need to develop a new analgesic index with improved performance to quantify postoperative pain in conscious patients. Objective: This study aimed to develop a new analgesic index using photoplethysmogram (PPG) spectrograms and a convolutional neural network (CNN) to objectively assess pain in conscious patients. Methods: PPGs were obtained from a group of surgical patients for 6 minutes both in the absence (preoperatively) and in the presence (postoperatively) of pain. Then, the PPG data of the latter 5 minutes were used for analysis. Based on the PPGs and a CNN, we developed a spectrogram?CNN index for pain assessment. The area under the curve (AUC) of the receiver-operating characteristic curve was measured to evaluate the performance of the 2 indices. Results: PPGs from 100 patients were used to develop the spectrogram?CNN index. When there was pain, the mean (95% CI) spectrogram?CNN index value increased significantly?baseline: 28.5 (24.2-30.7) versus recovery area: 65.7 (60.5-68.3); P<.01. The AUC and balanced accuracy were 0.76 and 71.4%, respectively. The spectrogram?CNN index cutoff value for detecting pain was 48, with a sensitivity of 68.3% and specificity of 73.8%. Conclusions: Although there were limitations to the study design, we confirmed that the spectrogram?CNN index can efficiently detect postoperative pain in conscious patients. Further studies are required to assess the spectrogram?CNN index?s feasibility and prevent overfitting to various populations, including patients under general anesthesia. Trial Registration: Clinical Research Information Service KCT0002080; https://cris.nih.go.kr/cris/search/search_result_st01.jsp?seq=6638 UR - http://www.jmir.org/2021/2/e23920/ UR - http://dx.doi.org/10.2196/23920 UR - http://www.ncbi.nlm.nih.gov/pubmed/33533723 ID - info:doi/10.2196/23920 ER - TY - JOUR AU - Elbers, Stefan AU - van Gessel, Christa AU - Renes, Jan Reint AU - van der Lugt, Remko AU - Wittink, Harriët AU - Hermsen, Sander PY - 2021/1/20 TI - Innovation in Pain Rehabilitation Using Co-Design Methods During the Development of a Relapse Prevention Intervention: Case Study JO - J Med Internet Res SP - e18462 VL - 23 IS - 1 KW - co-design KW - participatory design KW - chronic pain KW - intervention development KW - rehabilitation KW - behavior change KW - relapse KW - prevention N2 - Background: Many intervention development projects fail to bridge the gap from basic research to clinical practice. Instead of theory-based approaches to intervention development, co-design prioritizes the end users? perspective as well as continuous collaboration between stakeholders, designers, and researchers throughout the project. This alternative approach to the development of interventions is expected to promote the adaptation to existing treatment activities and to be responsive to the requirements of end users. Objective: The first objective was to provide an overview of all activities that were employed during the course of a research project to develop a relapse prevention intervention for interdisciplinary pain treatment programs. The second objective was to examine how co-design may contribute to stakeholder involvement, generation of relevant insights and ideas, and incorporation of stakeholder input into the intervention design. Methods: We performed an embedded single case study and used the double diamond model to describe the process of intervention development. Using all available data sources, we also performed deductive content analysis to reflect on this process. Results: By critically reviewing the value and function of a co-design project with respect to idea generation, stakeholder involvement, and incorporation of stakeholder input into the intervention design, we demonstrated how co-design shaped the transition from ideas, via concepts, to a prototype for a relapse prevention intervention. Conclusions: Structural use of co-design throughout the project resulted in many different participating stakeholders and stimulating design activities. As a consequence, the majority of the components of the final prototype can be traced back to the information that stakeholders provided during the project. Although this illustrates how co-design facilitates the integration of contextual information into the intervention design, further experimental testing is required to evaluate to what extent this approach ultimately leads to improved usability as well as patient outcomes in the context of clinical practice. UR - http://www.jmir.org/2021/1/e18462/ UR - http://dx.doi.org/10.2196/18462 UR - http://www.ncbi.nlm.nih.gov/pubmed/33470937 ID - info:doi/10.2196/18462 ER - TY - JOUR AU - Garcia, M. Laura AU - Darnall, D. Beth AU - Krishnamurthy, Parthasarathy AU - Mackey, G. Ian AU - Sackman, Josh AU - Louis, G. Robert AU - Maddox, Todd AU - Birckhead, J. Brandon PY - 2021/1/19 TI - Self-Administered Behavioral Skills?Based At-Home Virtual Reality Therapy for Chronic Low Back Pain: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e25291 VL - 10 IS - 1 KW - chronic pain KW - virtual reality KW - behavioral medicine KW - behavioral health KW - pain treatment KW - randomized controlled trial N2 - Background: Chronic pain is one of the most common and debilitating health conditions. Treatments for chronic low back pain typically focus on biomedical treatment approaches. While psychosocial treatments exist, multiple barriers prevent broad access. There is a significant unmet need for integrative, easily accessible, non-opioid solutions for chronic pain. Virtual reality (VR) is an immersive technology allowing innovation in the delivery of behavioral pain treatments. Behavioral skills-based VR is effective at facilitating pain management and reducing pain-related concerns. Continued research on these emerging approaches is needed. Objective: In this randomized controlled trial, we seek to test the efficacy of a self-administered behavioral skills-based VR program as a nonpharmacological home-based pain management treatment for people with chronic low back pain (cLBP). Methods: We will randomize 180 individuals with cLBP to 1 of 2 VR programs: (1) EaseVRx (8-week skills-based VR program); or (2) Sham VR (control condition). All participants will receive a VR headset to minimize any biases related to the technology?s novelty. The Sham VR group had 2D neutral content in a 3D theater-like environment. Our primary outcome is average pain intensity and pain-related interference with activity, stress, mood, and sleep. Our secondary outcomes include patient-reported physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, health utilization, medication use, and user satisfaction. We hypothesize superiority for the skills-based VR program in all of these measures compared to the control condition. Team statisticians blinded to treatment assignment will assess outcomes up to 6 months posttreatment using an approach suitable for the longitudinal nature of the data. Results: The study was approved by the Western Institutional Review Board on July 2, 2020. The protocol (NCT04415177) was registered on May 27, 2020. Recruitment for this study was completed in July 2020, and data collection will remain active until March 2021. In total, 186 participants were recruited. Multiple manuscripts will be generated from this study. The primary manuscript will be submitted for publication in the winter of 2020. Conclusions: Effectively delivering behavioral treatments in VR could overcome barriers to care and provide scalable solutions to chronic pain?s societal burden. Our study could help shape future research and development of these innovative approaches. Trial Registration: ClinicalTrials.gov NCT04415177; https://clinicaltrials.gov/ct2/show/NCT04415177 International Registered Report Identifier (IRRID): RR1-10.2196/25291 UR - https://www.researchprotocols.org/2021/1/e25291 UR - http://dx.doi.org/10.2196/25291 UR - http://www.ncbi.nlm.nih.gov/pubmed/33464215 ID - info:doi/10.2196/25291 ER - TY - JOUR AU - Hill, Adele AU - Joyner, H. Christopher AU - Keith-Jopp, Chloe AU - Yet, Barbaros AU - Tuncer Sakar, Ceren AU - Marsh, William AU - Morrissey, Dylan PY - 2021/1/15 TI - A Bayesian Network Decision Support Tool for Low Back Pain Using a RAND Appropriateness Procedure: Proposal and Internal Pilot Study JO - JMIR Res Protoc SP - e21804 VL - 10 IS - 1 KW - back pain KW - decision making KW - Bayesian methods KW - consensus N2 - Background: Low back pain (LBP) is an increasingly burdensome condition for patients and health professionals alike, with consistent demonstration of increasing persistent pain and disability. Previous decision support tools for LBP management have focused on a subset of factors owing to time constraints and ease of use for the clinician. With the explosion of interest in machine learning tools and the commitment from Western governments to introduce this technology, there are opportunities to develop intelligent decision support tools. We will do this for LBP using a Bayesian network, which will entail constructing a clinical reasoning model elicited from experts. Objective: This paper proposes a method for conducting a modified RAND appropriateness procedure to elicit the knowledge required to construct a Bayesian network from a group of domain experts in LBP, and reports the lessons learned from the internal pilot of the procedure. Methods: We propose to recruit expert clinicians with a special interest in LBP from across a range of medical specialties, such as orthopedics, rheumatology, and sports medicine. The procedure will consist of four stages. Stage 1 is an online elicitation of variables to be considered by the model, followed by a face-to-face workshop. Stage 2 is an online elicitation of the structure of the model, followed by a face-to-face workshop. Stage 3 consists of an online phase to elicit probabilities to populate the Bayesian network. Stage 4 is a rudimentary validation of the Bayesian network. Results: Ethical approval has been obtained from the Research Ethics Committee at Queen Mary University of London. An internal pilot of the procedure has been run with clinical colleagues from the research team. This showed that an alternating process of three remote activities and two in-person meetings was required to complete the elicitation without overburdening participants. Lessons learned have included the need for a bespoke online elicitation tool to run between face-to-face meetings and for careful operational definition of descriptive terms, even if widely clinically used. Further, tools are required to remotely deliver training about self-identification of various forms of cognitive bias and explain the underlying principles of a Bayesian network. The use of the internal pilot was recognized as being a methodological necessity. Conclusions: We have proposed a method to construct Bayesian networks that are representative of expert clinical reasoning for a musculoskeletal condition in this case. We have tested the method with an internal pilot to refine the process prior to deployment, which indicates the process can be successful. The internal pilot has also revealed the software support requirements for the elicitation process to model clinical reasoning for a range of conditions. International Registered Report Identifier (IRRID): DERR1-10.2196/21804 UR - http://www.researchprotocols.org/2021/1/e21804/ UR - http://dx.doi.org/10.2196/21804 UR - http://www.ncbi.nlm.nih.gov/pubmed/33448937 ID - info:doi/10.2196/21804 ER - TY - JOUR AU - Mardini, T. Mamoun AU - Nerella, Subhash AU - Kheirkhahan, Matin AU - Ranka, Sanjay AU - Fillingim, B. Roger AU - Hu, Yujie AU - Corbett, B. Duane AU - Cenko, Erta AU - Weber, Eric AU - Rashidi, Parisa AU - Manini, M. Todd PY - 2021/1/13 TI - The Temporal Relationship Between Ecological Pain and Life-Space Mobility in Older Adults With Knee Osteoarthritis: A Smartwatch-Based Demonstration Study JO - JMIR Mhealth Uhealth SP - e19609 VL - 9 IS - 1 KW - ecological momentary assessment KW - smartwatch app KW - life-space mobility KW - pain KW - knee osteoarthritis KW - global positioning system N2 - Background: Older adults who experience pain are more likely to reduce their community and life-space mobility (ie, the usual range of places in an environment in which a person engages). However, there is significant day-to-day variability in pain experiences that offer unique insights into the consequences on life-space mobility, which are not well understood. This variability is complex and cannot be captured with traditional recall-based pain surveys. As a solution, ecological momentary assessments record repeated pain experiences throughout the day in the natural environment. Objective: The aim of this study was to examine the temporal association between ecological momentary assessments of pain and GPS metrics in older adults with symptomatic knee osteoarthritis by using a smartwatch platform called Real-time Online Assessment and Mobility Monitor. Methods: Participants (n=19, mean 73.1 years, SD 4.8; female: 13/19, 68%; male: 6/19, 32%) wore a smartwatch for a mean period of 13.16 days (SD 2.94). Participants were prompted in their natural environment about their pain intensity (range 0-10) at random time windows in the morning, afternoon, and evening. GPS coordinates were collected at 15-minute intervals and aggregated each day into excursion, ellipsoid, clustering, and trip frequency features. Pain intensity ratings were averaged across time windows for each day. A random effects model was used to investigate the within and between-person effects. Results: The daily mean pain intensities reported by participants ranged between 0 and 8 with 40% reporting intensities ?2. The within-person associations between pain intensity and GPS features were more likely to be statistically significant than those observed between persons. Within-person pain intensity was significantly associated with excursion size, and others (excursion span, total distance, and ellipse major axis) showed a statistical trend (excursion span: P=.08; total distance: P=.07; ellipse major axis: P=.07). Each point increase in the mean pain intensity was associated with a 3.06 km decrease in excursion size, 2.89 km decrease in excursion span, 5.71 km decrease total distance travelled per day, 31.4 km2 decrease in ellipse area, 0.47 km decrease ellipse minor axis, and 3.64 km decrease in ellipse major axis. While not statistically significant, the point estimates for number of clusters (P=.73), frequency of trips (P=.81), and homestay (P=.15) were positively associated with pain intensity, and entropy (P=.99) was negatively associated with pain intensity. Conclusions: In this demonstration study, higher intensity knee pain in older adults was associated with lower life-space mobility. Results demonstrate that a custom-designed smartwatch platform is effective at simultaneously collecting rich information about ecological pain and life-space mobility. Such smart tools are expected to be important for remote health interventions that harness the variability in pain symptoms while understanding their impact on life-space mobility. UR - http://mhealth.jmir.org/2021/1/e19609/ UR - http://dx.doi.org/10.2196/19609 UR - http://www.ncbi.nlm.nih.gov/pubmed/33439135 ID - info:doi/10.2196/19609 ER - TY - JOUR AU - Sjöberg, Veronica AU - Westergren, Jens AU - Monnier, Andreas AU - Lo Martire, Riccardo AU - Hagströmer, Maria AU - Äng, Olov Björn AU - Vixner, Linda PY - 2021/1/12 TI - Wrist-Worn Activity Trackers in Laboratory and Free-Living Settings for Patients With Chronic Pain: Criterion Validity Study JO - JMIR Mhealth Uhealth SP - e24806 VL - 9 IS - 1 KW - chronic pain KW - energy expenditure KW - heart rate KW - physical activity KW - step count KW - validity KW - wearable devices KW - wearable KW - pain KW - rehabilitation N2 - Background: Physical activity is evidently a crucial part of the rehabilitation process for patients with chronic pain. Modern wrist-worn activity tracking devices seemingly have a great potential to provide objective feedback and assist in the adoption of healthy physical activity behavior by supplying data of energy expenditure expressed as metabolic equivalent of task units (MET). However, no studies of any wrist-worn activity tracking devices? have examined criterion validity in estimating energy expenditure, heart rate, or step count in patients with chronic pain. Objective: The aim was to determine the criterion validity of wrist-worn activity tracking devices for estimations of energy expenditure, heart rate, and step count in a controlled laboratory setting and free-living settings for patients with chronic pain. Methods: In this combined laboratory and field validation study, energy expenditure, heart rate, and step count were simultaneously estimated by a wrist-worn activity tracker (Fitbit Versa), indirect calorimetry (Jaeger Oxycon Pro), and a research-grade hip-worn accelerometer (ActiGraph GT3X) during treadmill walking at 3 speeds (3.0 km/h, 4.5 km/h, and 6.0 km/h) in the laboratory setting. Energy expenditure and step count were also estimated by the wrist-worn activity tracker in free-living settings for 72 hours. The criterion validity of each measure was determined using intraclass and Spearman correlation, Bland-Altman plots, and mean absolute percentage error. An analysis of variance was used to determine whether there were any significant systematic differences between estimations. Results: A total of 42 patients (age: 25-66 years; male: 10/42, 24%; female: 32/42, 76%), living with chronic pain (duration, in years: mean 9, SD 6.72) were included. At baseline, their mean pain intensity was 3.5 (SD 1.1) out of 6 (Multidimensional Pain Inventory, Swedish version). Results showed that the wrist-worn activity tracking device (Fitbit Versa) systematically overestimated energy expenditure when compared to the criterion standard (Jaeger Oxycon Pro) and the relative criterion standard (ActiGraph GT3X). Poor agreement and poor correlation were shown between Fitbit Versa and both Jaeger Oxycon Pro and ActiGraph GT3X for estimated energy expenditure at all treadmill speeds. Estimations of heart rate demonstrated poor to fair agreement during laboratory-based treadmill walks. For step count, the wrist-worn devices showed fair agreement and fair correlation at most treadmill speeds. In free-living settings; however, the agreement for step count between the wrist-worn device and waist-worn accelerometer was good, and the correlation was excellent. Conclusions: The wrist-worn device systematically overestimated energy expenditure and showed poor agreement and correlation compared to the criterion standard (Jaeger Oxycon Pro) and the relative criterion standard (ActiGraph GT3X), which needs to be considered when used clinically. Step count measured with a wrist-worn device, however, seemed to be a valid estimation, suggesting that future guidelines could include such variables in this group with chronic pain. UR - http://mhealth.jmir.org/2021/1/e24806/ UR - http://dx.doi.org/10.2196/24806 UR - http://www.ncbi.nlm.nih.gov/pubmed/33433391 ID - info:doi/10.2196/24806 ER - TY - JOUR AU - Xie, Su-Hang AU - Wang, Qian AU - Wang, Li-Qiong AU - Wang, Lin AU - Song, Kang-Ping AU - He, Cheng-Qi PY - 2021/1/5 TI - Effect of Internet-Based Rehabilitation Programs on Improvement of Pain and Physical Function in Patients with Knee Osteoarthritis: Systematic Review and Meta-analysis of Randomized Controlled Trials JO - J Med Internet Res SP - e21542 VL - 23 IS - 1 KW - internet-based rehabilitation KW - knee KW - osteoarthritis KW - pain KW - physical function KW - meta-analysis KW - review KW - telerehabilitation KW - eHealth KW - telemedicine N2 - Background: Osteoarthritis (OA) is a chronic, debilitating, and degenerative joint disease. However, it is difficult for patients with knee OA to access conventional rehabilitation when discharging from the hospital. Internet-based rehabilitation is one of the promising telemedicine strategies to provide a means combining monitoring, guidance, and treatment for patients with knee OA. Objective: The aim of this study was to conduct a systematic review and meta-analysis for assessing the effect of internet-based rehabilitation programs on pain and physical function in patients with knee OA. Methods: Keywords related to knee OA and internet-based rehabilitation were systematically searched in the Web of Science, MEDLINE, EMBASE, CENTRAL, Scopus, PEDro (Physiotherapy Evidence Database), CNKI, SinoMed, and WANFANG databases from January 2000 to April 2020. Only randomized controlled trials were included. The authors independently screened the literature. The main outcome measures were focused on pain and physical function. A meta-analysis was performed on the collected data. Review Manager (RevMan, version 5.3) was used for all analyses. Results: The systematic review identified 6 randomized controlled trials, 4 of which were included in the meta-analysis, comprising a total of 791 patients with knee OA. The meta-analysis with the fixed-effects model showed that the internet-based rehabilitation programs could significantly alleviate the osteoarthritic pain for patients compared with conventional rehabilitation (standardized mean difference [SMD]??0.21, 95% CI???0.4 to ?0.01, P=.04). No significant difference was found in the improvement of physical function in patients with knee OA compared with conventional rehabilitation within 2 to 12 months (SMD??0.08, 95% CI??0.27 to 0.12, P=.43). Conclusions: This systematic review shows that internet-based rehabilitation programs could improve the pain but not physical function for patients with knee OA. However, there was a very small number of studies that could be included in the review and meta-analysis. Thus, further studies with large sample sizes are warranted to promote the effectiveness of internet-based rehabilitation and to develop its personalized design. UR - https://www.jmir.org/2021/1/e21542 UR - http://dx.doi.org/10.2196/21542 UR - http://www.ncbi.nlm.nih.gov/pubmed/33399542 ID - info:doi/10.2196/21542 ER - TY - JOUR AU - Mace, A. Ryan AU - Doorley, D. James AU - Popok, J. Paula AU - Vranceanu, Ana-Maria PY - 2021/1/4 TI - Live Video Adaptations to a Mind-Body Activity Program for Chronic Pain and Cognitive Decline: Protocol for the Virtual Active Brains Study JO - JMIR Res Protoc SP - e25351 VL - 10 IS - 1 KW - chronic pain KW - cognitive decline KW - physical activity KW - mind-body therapies KW - aged KW - telemedicine KW - mobile phone N2 - Background: Chronic pain (CP) and cognitive decline (CD) are costly, challenging to treat, prevalent among older adults, and worsen each other over time. We are iteratively developing Active Brains-Fitbit (AB-F), a live video program for older adults with CP and CD that teaches mind-body skills and gradual increases in step count. AB-F has demonstrated feasibility; acceptability; and signs of improvement in emotional, physical, and cognitive functions when delivered in person to older adults. Objective: We are conducting a feasibility randomized controlled trial (RCT) of AB-F versus a time- and dose-matched educational control (health enhancement program [HEP]) in older adults with CP and CD. Here, we describe virtual adaptions to our study protocol, manualized treatments, evaluation plan, and study design in response to feedback from former participants and COVID-19. We will evaluate the feasibility benchmarks and the potential of AB-F to improve physical, emotional, and cognitive functions. Methods: This is a single-blind pilot RCT. Participants are randomized to AB-F or HEP. Patients are recruited through pain clinic referrals, institutional registries, and flyers. Interested participants are screened for eligibility via telephone and provide electronic informed consent. After randomization, participants are mailed all study documents, including their treatment manual, an ActiGraph accelerometer, and a Fitbit (separate envelope for AB-F only). Both conditions are manualized and delivered over 8 weekly sessions via Zoom. Participants complete self-report and performance-based (6-min walk test and Montreal Cognitive Assessment) outcome measures via Zoom at baseline and post intervention. Primary outcomes are a priori set feasibility (recruitment, quantitative measures, and adherence), acceptability, credibility, expectancy, and satisfaction benchmarks. Secondary outcomes are physical, cognitive, and emotional functions as well as intervention targets (social function, pain intensity, pain-specific coping, and mindfulness). Results: The trial is ongoing. We have recruited 21 participants (10 AB-F and 11 HEP) across 2 rounds. Only 2 participants have withdrawn (1 before baseline and 1 before the first session). All 19 remaining participants have completed the baseline assessment. In the first round, attendance is high (11 out of 12 participants completed all 4 sessions so far), and AB-F participants are adherent to their Fitbit and step goals (5 out of 6 participants). Conclusions: Preliminary findings are promising for the feasibility of our completely virtual AB-F intervention. However, these findings need to be confirmed at the trial conclusion. This study will answer important questions about the feasibility of delivering a completely virtual mind-body activity program to older adults with comorbid CP and CD, which, to our knowledge, is unprecedented. Details on integrating multiple digital platforms for virtual assessments and intervention delivery will inform treatment development for older adults and those with comorbid CP and CD, which is crucial during the COVID-19 pandemic. Trial Registration: ClinicalTrials.gov NCT04044183; https://clinicaltrials.gov/ct2/show/NCT04044183 International Registered Report Identifier (IRRID): DERR1-10.2196/25351 UR - https://www.researchprotocols.org/2021/1/e25351 UR - http://dx.doi.org/10.2196/25351 UR - http://www.ncbi.nlm.nih.gov/pubmed/33208301 ID - info:doi/10.2196/25351 ER - TY - JOUR AU - Clarkson, Paul AU - Vassilev, Ivaylo AU - Rogers, Anne AU - Brooks, Charlotte AU - Wilson, Nicky AU - Lawson, Jem AU - Adams, Jo PY - 2020/11/26 TI - Integrating a Web-Based Self-Management Tool (Managing Joint Pain on the Web and Through Resources) for People With Osteoarthritis-Related Joint Pain With a Web-Based Social Network Support Tool (Generating Engagement in Network Involvement): Design, Development, and Early Evaluation JO - JMIR Form Res SP - e18565 VL - 4 IS - 11 KW - joint pain KW - osteoarthritis KW - internet KW - self-management KW - social networks N2 - Background: Joint pain caused by osteoarthritis (OA) is highly prevalent and can be extremely debilitating. Programs to support self-management of joint pain can be effective; however, most programs are designed to build self-efficacy and rarely engage social networks. Digital interventions are considered acceptable by people with joint pain. However, many existing resources are not accessible for or developed alongside people with lower health literacy, which disproportionately affects people with OA. Objective: This study aims to design and develop an accessible digital self-management tool for people with joint pain and integrate this with an existing social network activation tool (Generating Engagement in Network Involvement [GENIE]) and to explore the feasibility of these linked tools for supporting the management of joint pain. Methods: The study was conducted in 2 phases: a design and development stage and a small-scale evaluation. The first phase followed the person-based approach to establish guiding principles for the development of a new site (Managing joint Pain On the Web and through Resources [EMPOWER]) and its integration with GENIE. People with joint pain were recruited from libraries, a community café, and an exercise scheme to take part in 3 focus groups. EMPOWER was tested and refined using think-aloud interviews (n=6). In the second phase, participants were recruited through the web via libraries to participate in a small-scale evaluation using the LifeGuide platform to record use over a 1-month period. Participants (n=6) were asked to complete evaluation questionnaires on their experiences. The NASSS (nonadoption, abandonment, scale-up, spread, and sustainability) framework was used to explore the feasibility of the sites. Results: The focus groups established guiding principles for the development of the tool. These included ensuring accessibility and relevance for people with OA-related joint pain and recognizing that joint pain is the reason for seeking support, trust, social facilitation, and goal setting. Think-aloud interviews identified issues with user experience and site navigation and the need for professional input for referral and goal setting, confusion, and tensions over the role of GENIE and site connectivity. Participants expected the sites to be specific to their pain-related needs. EMPOWER was accessed 18 times; 6 users registered with the site during the evaluation study. Participants mostly explored information pages on being active and being a healthy weight. Only one participant undertook goal setting and 4 participants visited the GENIE website. Conclusions: Using the NASSS framework, we identified the complexity associated with integrating EMPOWER and GENIE. The value proposition domain highlighted the technical and conceptual complexity associated with integrating approaches. Although identified as theoretically achievable, the integration of differing propositions may have caused cognitive and practical burdens for users. Nevertheless, we believe that both approaches have a distinct role in the self-management of joint pain. UR - http://formative.jmir.org/2020/11/e18565/ UR - http://dx.doi.org/10.2196/18565 UR - http://www.ncbi.nlm.nih.gov/pubmed/33242011 ID - info:doi/10.2196/18565 ER - TY - JOUR AU - Griffin, Anya AU - Wilson, Luke AU - Feinstein, B. Amanda AU - Bortz, Adeline AU - Heirich, S. Marissa AU - Gilkerson, Rachel AU - Wagner, FM Jenny AU - Menendez, Maria AU - Caruso, J. Thomas AU - Rodriguez, Samuel AU - Naidu, Srinivas AU - Golianu, Brenda AU - Simons, E. Laura PY - 2020/11/23 TI - Virtual Reality in Pain Rehabilitation for Youth With Chronic Pain: Pilot Feasibility Study JO - JMIR Rehabil Assist Technol SP - e22620 VL - 7 IS - 2 KW - digital health care KW - virtual reality KW - immersive technology KW - chronic pain management KW - adolescents N2 - Background: In the field of pain, virtual reality (VR) technology has been increasingly common in the context of procedural pain management. As an interactive technology tool, VR has the potential to be extended beyond acute pain management to chronic pain rehabilitation with a focus on increasing engagement with painful or avoided movements. Objective: We outline the development and initial implementation of a VR program in pain rehabilitation intervention to enhance function in youth with chronic pain. Methods: We present the development, acceptability, feasibility, and utility of an innovative VR program (Fruity Feet) for pediatric pain rehabilitation to facilitate increased upper and lower extremity engagement. The development team was an interdisciplinary group of pediatric experts, including physical therapists, occupational therapists, pain psychologists, anesthesiologists, pain researchers, and a VR software developer. We used a 4-phase iterative development process that engaged clinicians, parents, and patients via interviews and standardized questionnaires. Results: This study included 17 pediatric patients (13 female, 4 male) enrolled in an intensive interdisciplinary pain treatment (IIPT) program, with mean age of 13.24 (range 7-17) years, completing a total of 63 VR sessions. Overall reports of presence were high (mean 28.98; max 40; SD 4.02), suggestive of a high level of immersion. Among those with multisession data (n=8), reports of pain (P<.001), fear (P=.003), avoidance (P=.004), and functional limitations (P=.01) significantly decreased. Qualitative analysis revealed (1) a positive experience with VR (eg, enjoyed VR, would like to utilize the VR program again, felt VR was a helpful tool); (2) feeling distracted from pain while engaged in VR; (3) greater perceived mobility; and (4) fewer clinician-observed pain behaviors during VR. Movement data support the targeted impact of the Fruity Feet compared to other available VR programs. Conclusions: The iterative development process yielded a highly engaging and feasible VR program based on qualitative feedback, questionnaires, and movement data. We discuss next steps for the refinement, implementation, and assessment of impact of VR on chronic pain rehabilitation. VR holds great promise as a tool to facilitate therapeutic gains in chronic pain rehabilitation in a manner that is highly reinforcing and fun. UR - http://rehab.jmir.org/2020/2/e22620/ UR - http://dx.doi.org/10.2196/22620 UR - http://www.ncbi.nlm.nih.gov/pubmed/33226346 ID - info:doi/10.2196/22620 ER - TY - JOUR AU - Malliaras, Peter AU - Cridland, Kate AU - Hopmans, Ruben AU - Ashton, Simon AU - Littlewood, Chris AU - Page, Richard AU - Harris, Ian AU - Skouteris, Helen AU - Haines, Terry PY - 2020/11/18 TI - Internet and Telerehabilitation-Delivered Management of Rotator Cuff?Related Shoulder Pain (INTEL Trial): Randomized Controlled Pilot and Feasibility Trial JO - JMIR Mhealth Uhealth SP - e24311 VL - 8 IS - 11 KW - rotator cuff KW - tendinopathy KW - shoulder KW - telemedicine KW - telerehabilitation KW - randomized controlled trial KW - pilot KW - feasibility KW - pain KW - internet-delivered intervention N2 - Background: Rotator cuff?related shoulder pain (RCRSP) is a common and disabling musculoskeletal condition. Internet-based and telerehabilitation delivery of recommended care may improve access to care and improve adherence and outcomes. Objective: The primary aim of this pilot randomized controlled trial was to assess the feasibility of a 12-week internet-delivered intervention for RCRSP comparing advice only, recommended care, and recommended care with group-based telerehabilitation. Methods: Reporting was in accordance with the Consolidated Standards of Reporting Trials (CONSORT) checklist for pilot and feasibility trials. People with a primary complaint of RCRSP for 3 months or longer were identified via a paid Facebook strategy. Screening involved an online questionnaire followed by a 20-minute telehealth assessment. Participants were randomly allocated (via a Zelen design) to receive (1) advice only, (2) recommended care (internet-delivered evidence-based exercise and education), or (3) recommended care and telerehabilitation (including a weekly group teleconference session). Progression criteria for a full-scale trial included (1) recruitment of 20% or greater of eligible participants, (2) acceptable adherence (two or more of the three prescribed weekly sessions) among 70% or greater of participants, (3) 80% or greater retention of participants, (4) absence of intervention-related serious adverse events, and (5) 80% or greater response rates to questionnaires. Secondary clinical and patient knowledge outcomes were collected (via email or text) at baseline, six weeks, and 12 weeks (for clinical and patient knowledge), and within-group change was reported descriptively. Results: We enrolled 36 of 38 (95%) eligible participants and all participants were recruited within a 3-week period. Of the 36 participants, 12 participants were allocated to each of the three trial arms. The mean age of participants was between 51 and 56 years, and 83% (10/12) to 92% (11/12) were female. Retention at the 12-week endpoint was 94% (34/36) and response to email questionnaires at other time points was 83% or greater. We found acceptable adherence (defined as greater than 70% of participants performing exercise 2 or 3 times/week) in the recommended care group with telerehabilitation but not in the recommended care group without telerehabilitation. There was a total of 24 adverse events over 108 person-months of observation. All adverse events were mild or moderate (mainly muscle and shoulder symptoms), with the exception of one instance of elective surgery (unrelated to the person?s shoulder condition). Conclusions: Our prespecified success criteria were met or exceeded, but there was a gender imbalance toward women. It is feasible to progress to a fully powered trial, but strategies to address the gender imbalance need to be implemented. Trial Registration: Australian New Zealand Clinical Trials Registry (ACTRN12620000248965); https://tinyurl.com/yy6eztf5 UR - http://mhealth.jmir.org/2020/11/e24311/ UR - http://dx.doi.org/10.2196/24311 UR - http://www.ncbi.nlm.nih.gov/pubmed/33206059 ID - info:doi/10.2196/24311 ER - TY - JOUR AU - Carlson, A. Luke AU - Jeffery, M. Molly AU - Fu, Sunyang AU - He, Huan AU - McCoy, G. Rozalina AU - Wang, Yanshan AU - Hooten, Michael William AU - St Sauver, Jennifer AU - Liu, Hongfang AU - Fan, Jungwei PY - 2020/11/16 TI - Characterizing Chronic Pain Episodes in Clinical Text at Two Health Care Systems: Comprehensive Annotation and Corpus Analysis JO - JMIR Med Inform SP - e18659 VL - 8 IS - 11 KW - chronic pain KW - guideline development KW - knowledge representation KW - corpus annotation KW - content analysis N2 - Background: Chronic pain affects more than 20% of adults in the United States and is associated with substantial physical, mental, and social burden. Clinical text contains rich information about chronic pain, but no systematic appraisal has been performed to assess the electronic health record (EHR) narratives for these patients. A formal content analysis of the unstructured EHR data can inform clinical practice and research in chronic pain. Objective: We characterized individual episodes of chronic pain by annotating and analyzing EHR notes for a stratified cohort of adults with known chronic pain. Methods: We used the Rochester Epidemiology Project infrastructure to screen all residents of Olmsted County, Minnesota, for evidence of chronic pain, between January 1, 2005, and September 30, 2015. Diagnosis codes were used to assemble a cohort of 6586 chronic pain patients; people with cancer were excluded. The records of an age- and sex-stratified random sample of 62 patients from the cohort were annotated using an iteratively developed guideline. The annotated concepts included date, location, severity, causes, effects on quality of life, diagnostic procedures, medications, and other treatment modalities. Results: A total of 94 chronic pain episodes from 62 distinct patients were identified by reviewing 3272 clinical notes. Documentation was written by clinicians across a wide spectrum of specialties. Most patients (40/62, 65%) had 1 pain episode during the study period. Interannotator agreement ranged from 0.78 to 1.00 across the annotated concepts. Some pain-related concepts (eg, body location) had 100% (94/94) coverage among all the episodes, while others had moderate coverage (eg, effects on quality of life) (55/94, 59%). Back pain and leg pain were the most common types of chronic pain in the annotated cohort. Musculoskeletal issues like arthritis were annotated as the most common causes. Opioids were the most commonly captured medication, while physical and occupational therapies were the most common nonpharmacological treatments. Conclusions: We systematically annotated chronic pain episodes in clinical text. The rich content analysis results revealed complexity of the chronic pain episodes and of their management, as well as the challenges in extracting pertinent information, even for humans. Despite the pilot study nature of the work, the annotation guideline and corpus should be able to serve as informative references for other institutions with shared interest in chronic pain research using EHRs. UR - http://medinform.jmir.org/2020/11/e18659/ UR - http://dx.doi.org/10.2196/18659 UR - http://www.ncbi.nlm.nih.gov/pubmed/33108311 ID - info:doi/10.2196/18659 ER - TY - JOUR AU - Fritz, L. Roschelle AU - Wilson, Marian AU - Dermody, Gordana AU - Schmitter-Edgecombe, Maureen AU - Cook, J. Diane PY - 2020/11/6 TI - Automated Smart Home Assessment to Support Pain Management: Multiple Methods Analysis JO - J Med Internet Res SP - e23943 VL - 22 IS - 11 KW - pain KW - remote monitoring KW - sensors KW - smart homes KW - multiple methods N2 - Background: Poorly managed pain can lead to substance use disorders, depression, suicide, worsening health, and increased use of health services. Most pain assessments occur in clinical settings away from patients? natural environments. Advances in smart home technology may allow observation of pain in the home setting. Smart homes recognizing human behaviors may be useful for quantifying functional pain interference, thereby creating new ways of assessing pain and supporting people living with pain. Objective: This study aimed to determine if a smart home can detect pain-related behaviors to perform automated assessment and support intervention for persons with chronic pain. Methods: A multiple methods, secondary data analysis was conducted using historic ambient sensor data and weekly nursing assessment data from 11 independent older adults reporting pain across 1-2 years of smart home monitoring. A qualitative approach was used to interpret sensor-based data of 27 unique pain events to support clinician-guided training of a machine learning model. A periodogram was used to calculate circadian rhythm strength, and a random forest containing 100 trees was employed to train a machine learning model to recognize pain-related behaviors. The model extracted 550 behavioral markers for each sensor-based data segment. These were treated as both a binary classification problem (event, control) and a regression problem. Results: We found 13 clinically relevant behaviors, revealing 6 pain-related behavioral qualitative themes. Quantitative results were classified using a clinician-guided random forest technique that yielded a classification accuracy of 0.70, sensitivity of 0.72, specificity of 0.69, area under the receiver operating characteristic curve of 0.756, and area under the precision-recall curve of 0.777 in comparison to using standard anomaly detection techniques without clinician guidance (0.16 accuracy achieved; P<.001). The regression formulation achieved moderate correlation, with r=0.42. Conclusions: Findings of this secondary data analysis reveal that a pain-assessing smart home may recognize pain-related behaviors. Utilizing clinicians? real-world knowledge when developing pain-assessing machine learning models improves the model?s performance. A larger study focusing on pain-related behaviors is warranted to improve and test model performance. UR - http://www.jmir.org/2020/11/e23943/ UR - http://dx.doi.org/10.2196/23943 UR - http://www.ncbi.nlm.nih.gov/pubmed/33105099 ID - info:doi/10.2196/23943 ER - TY - JOUR AU - Smith, Vinayak AU - Warty, Rikain Ritesh AU - Sursas, Arun Joel AU - Payne, Olivia AU - Nair, Amrish AU - Krishnan, Sathya AU - da Silva Costa, Fabricio AU - Wallace, Morrison Euan AU - Vollenhoven, Beverley PY - 2020/11/2 TI - The Effectiveness of Virtual Reality in Managing Acute Pain and Anxiety for Medical Inpatients: Systematic Review JO - J Med Internet Res SP - e17980 VL - 22 IS - 11 KW - virtual reality KW - VR KW - pain management KW - anxiety KW - procedural pain KW - wound management KW - acute pain KW - analgesia KW - pain N2 - Background: Virtual reality is increasingly being utilized by clinicians to facilitate analgesia and anxiolysis within an inpatient setting. There is however, a lack of a clinically relevant review to guide its use for this purpose. Objective: To systematically review the current evidence for the efficacy of virtual reality as an analgesic in the management of acute pain and anxiolysis in an inpatient setting. Methods: A comprehensive search was conducted up to and including January 2019 on PubMed, Ovid Medline, EMBASE, and Cochrane Database of Systematic reviews according to PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Search terms included virtual reality, vr, and pain. Primary articles with a focus on acute pain in the clinical setting were considered for the review. Primary outcome measures included degree of analgesia afforded by virtual reality therapy, degree of anxiolysis afforded by virtual reality therapy, effect of virtual reality on physiological parameters, side effects precipitated by virtual reality, virtual reality content type, and type of equipment utilized. Results: Eighteen studies were deemed eligible for inclusion in this systematic review; 67% (12/18) of studies demonstrated significant reductions in pain with the utilization of virtual reality; 44% (8/18) of studies assessed the effects of virtual reality on procedural anxiety, with 50% (4/8) of these demonstrating significant reductions; 28% (5/18) of studies screened for side effects with incidence rates of 0.5% to 8%; 39% (7/18) of studies evaluated the effects of virtual reality on autonomic arousal as a biomarker of pain, with 29% (2/7) demonstrating significant changes; 100% (18/18) of studies utilized a head mounted display to deliver virtual reality therapy, with 50% being in active form (participants interacting with the environment) and 50% being in passive form (participants observing the content only). Conclusions: Available evidence suggests that virtual reality therapy can be applied to facilitate analgesia for acute pain in a variety of inpatient settings. Its effects, however, are likely to vary by patient population and indication. This highlights the need for individualized pilot testing of virtual reality therapy?s effects for each specific clinical use case rather than generalizing its use for the broad indication of facilitating analgesia. In addition, virtual reality therapy has the added potential of concurrently providing procedural anxiolysis, thereby improving patient experience and cooperation, while being associated with a low incidence of side effects (nausea, vomiting, eye strain, and dizziness). Furthermore, findings indicated a head mounted display should be utilized to deliver virtual reality therapy in a clinical setting with a slight preference for active over passive virtual reality for analgesia. There, however, appears to be insufficient evidence to substantiate the effect of virtual reality on autonomic arousal, and this should be considered at best to be for investigational uses, at present. UR - https://www.jmir.org/2020/11/e17980 UR - http://dx.doi.org/10.2196/17980 UR - http://www.ncbi.nlm.nih.gov/pubmed/33136055 ID - info:doi/10.2196/17980 ER - TY - JOUR AU - Yeh, Bo-Yan AU - Liu, Geng-Hao AU - Lee, Tzung-Yan AU - Wong, May-Kuen Alice AU - Chang, Hen-Hong AU - Chen, Yu-Sheng PY - 2020/10/26 TI - Efficacy of Electronic Acupuncture Shoes for Chronic Low Back Pain: Double-Blinded Randomized Controlled Trial JO - J Med Internet Res SP - e22324 VL - 22 IS - 10 KW - acupuncture KW - electronic acupuncture shoes KW - low back pain KW - medical device KW - self-treatment KW - mHealth N2 - Background: Chronic low back pain is a common problem and is associated with high costs, including those related to health care and indirect costs due to absence at work or reduced productivity. Previous studies have demonstrated that acupuncture or electroacupuncture can relieve low back pain. Electronic acupuncture shoes (EAS) are a novel device designed in this study. This device combines the properties of acupuncture and transcutaneous electrical nerve stimulation for clinical use. Objective: The aim of this study was to evaluate the efficacy of EAS in patients with chronic low back pain. Methods: In this prospective double-blinded randomized controlled study, the data of 83 patients who experienced chronic low back pain were analyzed. Patients came to our clinic for 20 visits and underwent assessment and treatment. Patients were randomly allocated to receive either EAS plus placebo nonsteroidal anti-inflammatory drugs (NSAIDs) (EAS group, n=42) or sham EAS plus NSAIDs (NSAID group, n=41). The visual analog scale (VAS) score and range of motion were assessed at baseline, before and after each EAS treatment, and 2 weeks after the last treatment. The time for achieving pain remission was recorded. Quality of life was assessed at the 2nd, 14th, and 20th visits. Results: After 6 weeks of treatment, the treatment success rate in each visit in the EAS group was higher than that in the NSAID group, as revealed by the intention-to-treat (ITT) and per-protocol (PP) analyses, but significant differences were observed only during the 16th visit in the ITT analysis (EAS group: 31/37, 84% and NSAID group: 21/34, 62%; P=.04). The change in the VAS score from baseline in each visit in the EAS group was greater than that in the NSAID group, as revealed by the ITT and PP analyses, and significant differences were observed in the 5th visit and 9th visit in the ITT analysis (P=.048 and P=.048, respectively). Significant differences were observed in the left rotation in the 2nd visit and 4th visit (P=.049 and P=.03, respectively). No significant differences were observed in the VAS score before and after treatment in each visit and in the quality of life in both groups. Conclusions: EAS might serve as a reliable alternative therapeutic tool for patients with chronic low back pain who are contraindicated for oral NSAIDs. Trial Registration: ClinicalTrials.gov NCT02468297https://clinicaltrials.gov/ct2/show/NCT02468297 UR - http://www.jmir.org/2020/10/e22324/ UR - http://dx.doi.org/10.2196/22324 UR - http://www.ncbi.nlm.nih.gov/pubmed/33104004 ID - info:doi/10.2196/22324 ER - TY - JOUR AU - Galve Villa, Maria AU - S Palsson, Thorvaldur AU - Cid Royo, Albert AU - R Bjarkam, Carsten AU - Boudreau, A. Shellie PY - 2020/10/26 TI - Digital Pain Mapping and Tracking in Patients With Chronic Pain: Longitudinal Study JO - J Med Internet Res SP - e21475 VL - 22 IS - 10 KW - eHealth KW - medical illustrations KW - pain perception KW - mHealth KW - pain measurement KW - disease progression KW - patient-reported outcome measures KW - musculoskeletal pain KW - mobile phone KW - surveys and questionnaires KW - pain management N2 - Background: Digital pain mapping allows for remote and ecological momentary assessment in patients over multiple time points spanning days to months. Frequent ecological assessments may reveal tendencies and fluctuations more clearly and provide insights into the trajectory of a patient?s pain. Objective: The primary aim of this study is to remotely map and track the intensity and distribution of pain and discomfort (eg, burning, aching, and tingling) in patients with nonmalignant spinal referred pain over 12 weeks using a web-based app for digital pain mapping. The secondary aim is to explore the barriers of use by determining the differences in clinical and user characteristics between patients with good (regular users) and poor (nonregular users) reporting compliance. Methods: Patients (N=91; n=53 women) with spinal referred pain were recruited using web-based and traditional in-house strategies. Patients were asked to submit weekly digital pain reports for 12 weeks. Each pain report consisted of digital pain drawings on a pseudo?three-dimensional body chart and pain intensity ratings. The pain drawings captured the distribution of pain and discomfort (pain quality descriptors) expressed as the total extent and location. Differences in weekly pain reports were explored using the total extent (pixels), current and usual pain intensity ratings, frequency of quality descriptor selection, and Jaccard similarity index. Validated e-questionnaires were completed at baseline to determine the patients? characteristics (adapted Danish National Spine Register), disability (Oswestry Disability Index and Neck Disability Index), and pain catastrophizing (Pain Catastrophizing Scale) profiles. Barriers of use were assessed at 6 weeks using a health care?related usability and acceptance e-questionnaire and a self-developed technology-specific e-questionnaire to assess the accessibility and ease of access of the pain mapping app. Associations between total extent, pain intensity, disability, and catastrophizing were explored to further understand pain. Differences between regular and nonregular users were assessed to understand the pain mapping app reporting compliance. Results: Fluctuations were identified in pain reports for total extent and pain intensity ratings (P<.001). However, quality descriptor selection (P=.99) and pain drawing (P=.49), compared using the Jaccard index, were similar over time. Interestingly, current pain intensity was greater than usual pain intensity (P<.001), suggesting that the timing of pain reporting coincided with a more intense pain experience than usual. Usability and acceptance were similar between regular and nonregular users. Regular users were younger (P<.001) and reported a larger total extent of pain than nonregular users (P<.001). Conclusions: This is the first study to examine digital reports of pain intensity and distribution in patients with nonmalignant spinal referred pain remotely for a sustained period and barriers of use and compliance using a digital pain mapping app. Differences in age, pain distribution, and current pain intensity may influence reporting behavior and compliance. UR - http://www.jmir.org/2020/10/e21475/ UR - http://dx.doi.org/10.2196/21475 UR - http://www.ncbi.nlm.nih.gov/pubmed/33104012 ID - info:doi/10.2196/21475 ER - TY - JOUR AU - Bostrøm, Katrine AU - Børøsund, Elin AU - Varsi, Cecilie AU - Eide, Hilde AU - Flakk Nordang, Elise AU - Schreurs, MG Karlein AU - Waxenberg, B. Lori AU - Weiss, E. Karen AU - Morrison, J. Eleshia AU - Cvancarova Småstuen, Milada AU - Stubhaug, Audun AU - Solberg Nes, Lise PY - 2020/10/23 TI - Digital Self-Management in Support of Patients Living With Chronic Pain: Feasibility Pilot Study JO - JMIR Form Res SP - e23893 VL - 4 IS - 10 KW - chronic pain KW - feasibility KW - acceptability KW - self-management KW - eHealth KW - digital KW - cognitive-behavioral pain KW - usability KW - user centered N2 - Background: Chronic pain can be complex and taxing to live with, and treatment and support require a multicomponent approach, which may not always be offered or available. Smartphones, tablets, and personal computers are already incorporated into patients? daily lives, and therefore, they can be used to communicate, educate, and support self-management. Although some web-based self-management interventions exist, research examining the evidence and effect of digital solutions supporting self-management for patients living with chronic pain is limited, findings are inconclusive, and new innovative ideas and solutions are needed. Objective: This feasibility pilot study aimed to explore the system use, perceived usefulness, ease of use, and preliminary effects of EPIO, an app-based cognitive-behavioral pain self-management intervention program for patients living with chronic pain. Methods: The EPIO intervention was delivered in a blended-care model containing (1) one face-to-face introduction session, (2) nine cognitive behavior?based pain self-management modules, delivered in an app-based format for smartphones or tablets, and (3) one follow-up phone call at 2 to 3 weeks after the introduction session. Patients living with chronic pain (N=50) completed pre-post outcome measures at baseline and 3 months after the introduction session, with registration of system use (ie, log data) until 6 months. The use, perceived usefulness, and ease of use of the EPIO program were examined through system use data, as well as a study-specific use/usability questionnaire and the System Usability Scale (SUS). Outcome measures to test feasibility of use and estimate preliminary effects included the Brief Pain Inventory, health-related quality of life (HRQoL) scale, Hospital Anxiety and Depression Scale, Self-Regulatory Fatigue scale, Pain Catastrophizing Scale, and Chronic Pain Acceptance Questionnaire. Results: Participants (N=50) had a median age of 52 years (range 29-74 years) at inclusion and were mainly female (40/50, 80%). Thirty-one participants completed at least six of the nine modules within the 3-month study period (62% completion rate). Forty-five participants completed outcome measures at 3 months, and the EPIO program was rated as useful (ie, ?totally agree? or ?agree?; 39/45, 87%) and easy to use (42/45, 93%), and as having easily understandable exercises (44/45, 98%). The average overall system usability (SUS) score was 85.7, indicating grade A and excellent system usability. Preliminary psychosocial outcome measure estimates showed primarily nonsignificant pre-post intervention improvements at 3 months, but with significant positive effects related to some aspects of HRQoL (bodily pain, P=.02 and change, P=.049). Conclusions:  Digital self-management intervention programs may be of use and support for patients living with chronic pain. In this feasibility study, EPIO showed an acceptable program completion rate and was rated as useful and easy to use, with excellent user satisfaction. Program optimization and efficacy testing in a large-scale randomized controlled trial are warranted and in progress. Trial Registration: ClinicalTrials.gov NCT03705104; https://clinicaltrials.gov/ct2/show/NCT03705104 UR - http://formative.jmir.org/2020/10/e23893/ UR - http://dx.doi.org/10.2196/23893 UR - http://www.ncbi.nlm.nih.gov/pubmed/33094734 ID - info:doi/10.2196/23893 ER - TY - JOUR AU - Lam, Julia AU - Svensson, Peter AU - Alstergren, Per PY - 2020/10/13 TI - Internet-Based Multimodal Pain Program With Telephone Support for Adults With Chronic Temporomandibular Disorder Pain: Randomized Controlled Pilot Trial JO - J Med Internet Res SP - e22326 VL - 22 IS - 10 KW - chronic pain KW - cognitive behavior therapy KW - combined modality therapy KW - facial pain KW - feasibility studies KW - health services research KW - internet-based intervention KW - occlusal splints KW - pilot projects KW - temporomandibular disorders N2 - Background: Chronic pain from temporomandibular disorders remains an undertreated condition with debate regarding the most effective treatment modalities. Objective: The aim of the study was to investigate the treatment effect of an internet-based multimodal pain program on chronic temporomandibular disorder pain and evaluate the feasibility of a larger randomized controlled trial. Methods: An unblinded randomized controlled pilot trial was conducted with 43 participants (34 females, 9 males; median age 27, IQR 23-37 years) with chronic temporomandibular pain. Participants were recruited within the Public Dental Health Service and randomized to intervention (n=20) or active control (n=23). The intervention comprised a dentist-assisted internet-based multimodal pain program with 7 modules based on cognitive behavior therapy and self-management principles. The control group received conventional occlusal splint therapy. Primary outcomes included characteristic pain intensity, pain-related disability, and jaw functional limitation. Secondary outcomes were depression, anxiety, catastrophizing, and stress. Outcomes were self-assessed through questionnaires sent by mail at 3 and 6 months after treatment start. Feasibility evaluation included testing the study protocol and estimation of recruitment and attrition rates in the current research setting. Results: Only 49% of participants (21/43) provided data at the 6-month follow-up (internet-based multimodal pain program: n=7; control: n=14). Of the 20 participants randomized to the internet-based multimodal pain program, 14 started treatment and 8 completed all 7 modules of the program. Between-group analysis showed no significant difference for any outcome measure at 3- or 6-month follow-up?characteristic pain intensity (3 months: P=.58; 6 months: P=.41), pain-related disability (3 months: P=.51; 6 months: P=.12), jaw functional limitation (3 months: P=.45; 6 months: P=.90), degree of depression (3 months: P=.64; 6 months: P=.65), anxiety (3 months: P=.93; 6 months: P=.31), stress (3 months: P=.66; 6 months: P=.74), or catastrophizing (3 months: P=.86; 6 months: P=.85). Within-group analysis in the internet-based multimodal pain program group showed a significant reduction in jaw functional limitation score at the 6-month follow-up compared to baseline (Friedman: ?2=10.2, P=.04; Wilcoxon: z=?2.3, P=.02). In the occlusal splint group, jaw function limitation was also reduced at the 6-month follow-up (Friedman: ?2=20.0, P=.045; Wilcoxon: z=?2.3, P=.02), and there was a reduction in characteristic pain intensity at the 3- and 6-month follow-up (Friedman: ?2=25.1, P=.01; Wilcoxon 3 months: z=?3.0, P=.003; Wilcoxon 6 months: z=-3.3, P=.001). Conclusions: This study was not able to demonstrate a difference in treatment outcome between an internet-based multimodal pain program and occlusal splint therapy in patients with chronic temporomandibular pain. However, the findings suggested that the internet-based multimodal pain program improves jaw function. The results also confirmed the treatment effect of occlusal splint therapy for chronic temporomandibular pain. Furthermore, because of the high attrition rate, this pilot study showed that a randomized controlled trial with this design is not feasible. Trial Registration: ClinicalTrials.gov NCT04363762; https://clinicaltrials.gov/show/NCT04363762 UR - http://www.jmir.org/2020/10/e22326/ UR - http://dx.doi.org/10.2196/22326 UR - http://www.ncbi.nlm.nih.gov/pubmed/33048053 ID - info:doi/10.2196/22326 ER - TY - JOUR AU - Turnbull, Alexandra AU - Sculley, Dean AU - Escalona-Marfil, Carles AU - Riu-Gispert, Lluís AU - Ruiz-Moreno, Jorge AU - Gironès, Xavier AU - Coda, Andrea PY - 2020/9/17 TI - Comparison of a Mobile Health Electronic Visual Analog Scale App With a Traditional Paper Visual Analog Scale for Pain Evaluation: Cross-Sectional Observational Study JO - J Med Internet Res SP - e18284 VL - 22 IS - 9 KW - pain KW - mobile app KW - mHealth KW - digital health KW - electronic visual analog scale KW - visual analog scale KW - symptom KW - eHealth KW - reliability N2 - Background: Accurate quantification of pain in a clinical setting is vital. The use of an electronic pain scale enables data to be collected, analyzed, and utilized much faster compared with traditional paper-based scales. The advancement of smart technology in pediatric and adult pain evaluation may offer opportunities to introduce easy-to-use and reliable pain assessment methods within different clinical settings. If promptly introduced within different pediatric and adult pain clinic services, validated and easily accessible mobile health pain apps may lead to early pain detection, promoting improvement in patient?s quality of life and leading to potentially less time off from school or work. Objective: This cross-sectional observational study aimed to investigate the interchangeability of an electronic visual analog scale (eVAS) app with a traditional paper visual analog scale (pVAS) among Australian children, adolescents, and adults for pain evaluation. Methods: Healthy participants (age range 10-75 years) were recruited from a sporting club and a secondary school in Melbourne (Australia). The data collection process involved application of pressure (8.5 kg/cm2) from a Wagner Force Dial FDK 20 to the midpoint of the thumb. The pressure was applied twice with a 5-minute interval. At each pressure application, participants were asked to randomly record their pain perception using the ?eVAS? accessible via the ?Interactive Clinics? app and the traditional pVAS. Statistical analysis was conducted to determine intermethod and intramethod reliabilities. Results: Overall, 109 healthy participants were recruited. Adults (mean age 42.43 years, SD 14.50 years) had excellent reliability, with an intraclass correlation coefficient (ICC) of 0.94 (95% CI 0.91-0.96). Children and adolescents (mean age 13.91 years, SD 2.89 years) had moderate-to-good intermethod and intramethod reliabilities, with an ICC of 0.80 (95% CI 0.70-0.87) and average ICC of 0.80 (95% CI 0.69-0.87), respectively. Conclusions: The eVAS app appears to be interchangeable compared with the traditional pVAS among children, adolescents, and adults. This pain evaluation method may offer new opportunities to introduce user-friendly and validated pain assessment apps for patients, clinicians, and allied health professionals. UR - http://www.jmir.org/2020/9/e18284/ UR - http://dx.doi.org/10.2196/18284 UR - http://www.ncbi.nlm.nih.gov/pubmed/32940621 ID - info:doi/10.2196/18284 ER - TY - JOUR AU - LeBaron, Virginia AU - Bennett, Rachel AU - Alam, Ridwan AU - Blackhall, Leslie AU - Gordon, Kate AU - Hayes, James AU - Homdee, Nutta AU - Jones, Randy AU - Martinez, Yudel AU - Ogunjirin, Emmanuel AU - Thomas, Tanya AU - Lach, John PY - 2020/8/26 TI - Understanding the Experience of Cancer Pain From the Perspective of Patients and Family Caregivers to Inform Design of an In-Home Smart Health System: Multimethod Approach JO - JMIR Form Res SP - e20836 VL - 4 IS - 8 KW - cancer KW - pain KW - sensors KW - smart health KW - caregiver KW - home based KW - palliative care KW - opioids KW - smart watch N2 - Background: Inadequately managed pain is a serious problem for patients with cancer and those who care for them. Smart health systems can help with remote symptom monitoring and management, but they must be designed with meaningful end-user input. Objective: This study aims to understand the experience of managing cancer pain at home from the perspective of both patients and family caregivers to inform design of the Behavioral and Environmental Sensing and Intervention for Cancer (BESI-C) smart health system. Methods: This was a descriptive pilot study using a multimethod approach. Dyads of patients with cancer and difficult pain and their primary family caregivers were recruited from an outpatient oncology clinic. The participant interviews consisted of (1) open-ended questions to explore the overall experience of cancer pain at home, (2) ranking of variables on a Likert-type scale (0, no impact; 5, most impact) that may influence cancer pain at home, and (3) feedback regarding BESI-C system prototypes. Qualitative data were analyzed using a descriptive approach to identity patterns and key themes. Quantitative data were analyzed using SPSS; basic descriptive statistics and independent sample t tests were run. Results: Our sample (n=22; 10 patient-caregiver dyads and 2 patients) uniformly described the experience of managing cancer pain at home as stressful and difficult. Key themes included (1) unpredictability of pain episodes; (2) impact of pain on daily life, especially the negative impact on sleep, activity, and social interactions; and (3) concerns regarding medications. Overall, taking pain medication was rated as the category with the highest impact on a patient?s pain (=4.79), followed by the categories of wellness (=3.60; sleep quality and quantity, physical activity, mood and oral intake) and interaction (=2.69; busyness of home, social or interpersonal interactions, physical closeness or proximity to others, and emotional closeness and connection to others). The category related to environmental factors (temperature, humidity, noise, and light) was rated with the lowest overall impact (=2.51). Patients and family caregivers expressed receptivity to the concept of BESI-C and reported a preference for using a wearable sensor (smart watch) to capture data related to the abrupt onset of difficult cancer pain. Conclusions: Smart health systems to support cancer pain management should (1) account for the experience of both the patient and the caregiver, (2) prioritize passive monitoring of physiological and environmental variables to reduce burden, and (3) include functionality that can monitor and track medication intake and efficacy; wellness variables, such as sleep quality and quantity, physical activity, mood, and oral intake; and levels of social interaction and engagement. Systems must consider privacy and data sharing concerns and incorporate feasible strategies to capture and characterize rapid-onset symptoms. UR - http://formative.jmir.org/2020/8/e20836/ UR - http://dx.doi.org/10.2196/20836 UR - http://www.ncbi.nlm.nih.gov/pubmed/32712581 ID - info:doi/10.2196/20836 ER - TY - JOUR AU - Darnall, D. Beth AU - Krishnamurthy, Parthasarathy AU - Tsuei, Jeannette AU - Minor, D. Jorge PY - 2020/7/7 TI - Self-Administered Skills-Based Virtual Reality Intervention for Chronic Pain: Randomized Controlled Pilot Study JO - JMIR Form Res SP - e17293 VL - 4 IS - 7 KW - chronic pain KW - virtual reality KW - behavioral medicine KW - self-management KW - mobile phone KW - randomized controlled trial N2 - Background: Patients with chronic pain often have limited access to comprehensive care that includes behavioral pain management strategies. Virtual reality (VR) is an immersive technology and emerging digital behavioral pain therapy with analgesic efficacy for acute pain. We found no scientific literature on skills-based VR behavioral programs for chronic pain populations. Objective: The primary aim of this study is to evaluate the feasibility of a self-administered VR program that included content and skills informed by evidence-based behavioral treatment for chronic pain. The secondary aim is to determine the preliminary efficacy of the VR program in terms of average pain intensity and pain-related interference with activity, stress, mood, and sleep, and its impact on pain-related cognition and self-efficacy. The tertiary aim was to conduct a randomized controlled trial (RCT) and compare the VR treatment with an audio-only treatment. This comparison isolated the immersive effects of the VR program, thereby informing potential mechanisms of effect. Methods: We conducted an RCT involving a web-based convenience sample of adults (N=97) aged 18-75 years with self-reported chronic nonmalignant low back pain or fibromyalgia, with an average pain intensity >4 over the past month and chronic pain duration >6 months. Enrolled participants were randomly assigned to 1 of 2 unblinded treatments: (1) VR: a 21-day, skills-based VR program for chronic pain; and (2) audio: an audio-only version of the 21-day VR program. The analytic data set included participants who completed at least 1 of 8 surveys administered during the intervention period: VR (n=39) and audio (n=35). Results: The VR and audio groups launched a total of 1067 and 1048 sessions, respectively. The majority of VR participants (n=19/25, 76%) reported no nausea or motion sickness. High satisfaction ratings were reported for VR (n=24/29, 83%) and audio (n=26/33, 72%). For VR efficacy, symptom improvement over time was found for each pain variable (all P<.001), with results strengthening after 2 weeks. Importantly, significant time×group effects were found in favor of the VR group for average pain intensity (P=.04), pain-related inference with activity (P=.005), sleep (P<.001), mood (P<.001), and stress (P=.003). For pain catastrophizing and pain self-efficacy, we found a significant declining trend for both treatment groups. Conclusions: High engagement and satisfaction combined with low levels of adverse effects support the feasibility and acceptability of at-home skills-based VR for chronic pain. A significant reduction in pain outcomes over the course of the 21-day treatment both within the VR group and compared with an audio-only version suggests that VR has the potential to provide enhanced treatment and greater improvement across a range of pain outcomes. These findings provide a foundation for future research on VR behavioral interventions for chronic pain. UR - https://formative.jmir.org/2020/7/e17293 UR - http://dx.doi.org/10.2196/17293 UR - http://www.ncbi.nlm.nih.gov/pubmed/32374272 ID - info:doi/10.2196/17293 ER - TY - JOUR AU - Kasaeyan Naeini, Emad AU - Jiang, Mingzhe AU - Syrjälä, Elise AU - Calderon, Michael-David AU - Mieronkoski, Riitta AU - Zheng, Kai AU - Dutt, Nikil AU - Liljeberg, Pasi AU - Salanterä, Sanna AU - Nelson, M. Ariana AU - Rahmani, M. Amir PY - 2020/7/1 TI - Prospective Study Evaluating a Pain Assessment Tool in a Postoperative Environment: Protocol for Algorithm Testing and Enhancement JO - JMIR Res Protoc SP - e17783 VL - 9 IS - 7 KW - pain measurement KW - pain, postoperative KW - acute pain KW - health monitoring KW - wearable electronic devices KW - machine learning KW - multimodal biosignals N2 - Background: Assessment of pain is critical to its optimal treatment. There is a high demand for accurate objective pain assessment for effectively optimizing pain management interventions. However, pain is a multivalent, dynamic, and ambiguous phenomenon that is difficult to quantify, particularly when the patient?s ability to communicate is limited. The criterion standard of pain intensity assessment is self-reporting. However, this unidimensional model is disparaged for its oversimplification and limited applicability in several vulnerable patient populations. Researchers have attempted to develop objective pain assessment tools through analysis of physiological pain indicators, such as electrocardiography, electromyography, photoplethysmography, and electrodermal activity. However, pain assessment by using only these signals can be unreliable, as various other factors alter these vital signs and the adaptation of vital signs to pain stimulation varies from person to person. Objective pain assessment using behavioral signs such as facial expressions has recently gained attention. Objective: Our objective is to further the development and research of a pain assessment tool for use with patients who are likely experiencing mild to moderate pain. We will collect observational data through wearable technologies, measuring facial electromyography, electrocardiography, photoplethysmography, and electrodermal activity. Methods: This protocol focuses on the second phase of a larger study of multimodal signal acquisition through facial muscle electrical activity, cardiac electrical activity, and electrodermal activity as indicators of pain and for building predictive models. We used state-of-the-art standard sensors to measure bioelectrical electromyographic signals and changes in heart rate, respiratory rate, and oxygen saturation. Based on the results, we further developed the pain assessment tool and reconstituted it with modern wearable sensors, devices, and algorithms. In this second phase, we will test the smart pain assessment tool in communicative patients after elective surgery in the recovery room. Results: Our human research protections application for institutional review board review was approved for this part of the study. We expect to have the pain assessment tool developed and available for further research in early 2021. Preliminary results will be ready for publication during fall 2020. Conclusions: This study will help to further the development of and research on an objective pain assessment tool for monitoring patients likely experiencing mild to moderate pain. International Registered Report Identifier (IRRID): DERR1-10.2196/17783 UR - https://www.researchprotocols.org/2020/7/e17783 UR - http://dx.doi.org/10.2196/17783 UR - http://www.ncbi.nlm.nih.gov/pubmed/32609091 ID - info:doi/10.2196/17783 ER -